Prostate Cancer

Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07567521

Sponsor: C Ray Therapeutics

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Participants must have the ability to understand and sign ICF.
• Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate.
• Participants must have progressive mCRPC after treatment of ARPI or taxane-based chemotherapy.
• Participant must have been diagnosed with mCRPC with documented progressive disease.
• Participants must have prior orchiectomy and/or ongoing androgen-deprivation therapy with a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L).
• Participants must have one or more PSMA-positive lesions whose PSMA uptake (SUVmax) is more than 2 fold of the blood pool.
• Participants with an ECOG performance status of 0
• 2.
• Participants must have adequate organ function
• For participants who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal Investigator during the study and for 6 months after last investigational product administration.

Exclusion Criteria:

• Participants with mixed histology of prostate cancer (e.g., neuroendocrine).
• Any FDG-positive and PSMA-negative target lesions.
• Any investigational agents and other concurrent chemotherapy, targeted therapy, biologic agents, immunotherapy, radioligand therapy (androgen-deprivation therapy excepted) within 28 days or 5 half-lives prior to day of administration, whichever is longer.
• Previous treatment with any conventional external beam radiotherapy including hemi-body radiation within 6 weeks before enrollment.
• Previous bone-targeted therapy cannot be taken with a stable dose within 4 weeks before enrollment.
• Known hypersensitivity to the components of the study therapy or its analogs.
• Transfusion for the sole purpose of making a participant eligible for study inclusion within 28 days before administration.
• A superscan as seen in the baseline bone scan.
• Concurrent serious (as determined by the Investigator) medical conditions.
• Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment.

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Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07611110

Sponsor: AstraZeneca

Phase: Phase 3

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• ≥ 18 years of age.
• Diagnosis of adenocarcinoma of prostate.
• Must have had prior orchiectomy and/or ongoing ADT and a castrate level of plasma/serum testosterone.
• Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and/or non-measurable) that is suitable for repeated assessment by CT and/or MRI and/or bone scan.
• Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.
• Previously treated with at least 1 taxane-based chemotherapy regimen for either metastatic hormone-sensitive prostate cancer or CRPC.
• Previously treated with at least 1 ARPI (eg, enzalutamide, abiraterone, etc.).
• Positive PSMA PET/CT scans, obtained with PSMA ligands (⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL).
• ECOG performance status of 0 to 2.
• Adequate organ and bone marrow function as described in study protocol.
• Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
• Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.

Exclusion Criteria:

• Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).
• Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3.
• Receipt of > 6 cycles of PSMA-directed β-emitting therapeutic RC.
• History of another primary malignancy, with exceptions.
• Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.
• Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
• Clinically significant ECG abnormalities, with exceptions.

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Condition: Prostate Cancer (Diagnosis), Clinically Significant Prostate Cancer

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT07614256

Sponsor: Guangxi Medical University

Phase:

Eligibility:

• Age: minimum 40 Years maximum 90 Years
• Gender: Male

Inclusion Criteria:

1. Subjects who are scheduled to undergo or have undergone prostate biopsy or radical prostatectomy.
2. Subjects who have completed standard-of-care preoperative multiparametric MRI (mpMRI) and transrectal ultrasound (TRUS) examinations.
3. Subjects with complete pathological diagnosis results available.
4. Age between 40 and 90 years.
5. Able and willing to provide written informed consent (for prospective cohort participants only).

Exclusion Criteria:

1. Prior history of pelvic radiation therapy or radical prostatectomy.
2. Incomplete or poor-quality mpMRI or TRUS images (e.g., motion artifacts, insufficient sequences).
3. Concurrent other primary malignant tumors.
4. Severe systemic diseases that may affect the evaluation of the prostate.
5. Subjects with incomplete clinical or pathological data.
6. Contraindications to MRI examination (e.g., incompatible metallic implants, severe claustrophobia).

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Condition: Intermediate Risk Prostate Cancer, High Risk Prostate Cancer, Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07393867

Sponsor: Martin T. King, MD, PhD

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 18 years of age and older.
• Eastern Oncology Group Status 0 to 1.
• Histologic diagnosis of prostate cancer.
• Prior screening MRI with at least one PI-RADS4 or PI-RADS 5 lesion, obtained within 180 days of screening.
• NCCN intermediate-risk or high-risk prostate cancer (Appendix B). All patients will be staged by MRI.
• Prior PSMA PET scan with at least one focal avid lesion greater than background prostate that is concordant with a lesion on MRI, obtained within 180 days of screening.
• Intention for SBRT (36.25 Gy/5 fraction) with focal boost (up to 50 Gy) to one MRI/PET-concordant lesion34.

Exclusion Criteria:

• Prior imaging (CT, bone scan, MRI, PSMA-PET/CT) showing nodal or distant disease.
• Intention to receive treatment intensification with secondary androgen receptor signaling inhibitors or chemotherapy.
• Clinical T4 disease.
• Prior ADT.
• Prior pelvic RT.
• Prior prostate surgery, including TURP.
• International prostate symptom score > 20.
• Prior urethral stricture.
• Prostate volume > 80 cc on MRI.
• Hip implants that cause artifacts over the prostate gland.
• Inability to discontinue anti-coagulation for fiducial marker placement.
• Active Crohn's disease or scleroderma.

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Condition: Prostate Cancer (Post Prostatectomy), Perioperative Anesthetic, Catheter-related Bladder Discomfort (CRBD)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07607990

Sponsor: Zhejiang University

Eligibility:

• Age: minimum 18 Years maximum 80 Years
• Gender: Male

Inclusion Criteria:

1. Aged 18 to 80 years old (inclusive);
2. American Society of Anesthesiologists (ASA) physical status classification Class I-III;
3. Undergoing elective laparoscopic radical prostatectomy under general anesthesia;
4. Having a clear understanding of the study, voluntarily participating, and providing informed consent signed by themselves or their family members.

Exclusion Criteria:

1. Pre-existing bladder diseases, such as overactive bladder (frequency of micturition > 3 times per night or > 8 times within 24 hours), neurogenic bladder, and bladder outlet obstruction;
2. Postoperative status of pelvic organs or spine that affects bladder function;
3. Postoperative status of total proctocolectomy;
4. Severe cardiac insufficiency (activity tolerance < 4 METs) or clearly diagnosed coronary heart disease;
5. Clearly diagnosed chronic obstructive pulmonary disease (COPD) or a history of asthma;
6. Hepatic insufficiency with Child-Pugh Class C;
7. Chronic kidney disease requiring dialysis;
8. Active peptic ulcer/hemorrhagic disease;
9. Body mass index (BMI) ≤ 18 kg/m² or ≥ 28 kg/m²;
10. Chronic analgesic abuse;
11. Use of other nonsteroidal anti-inflammatory drugs (NSAIDs) within one week;
12. Hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs);
13. Mental or neurological disorders that prevent the completion of rating scales; or cognitive impairment resulting in the loss of capacity for civil conduct.

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Condition: Prostate Cancer (Adenocarcinoma)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07617272

Sponsor: Region Stockholm

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Biopsy-confirmed high-risk prostate cancer defined as: Global ISUP score > 3 with any MRI PI-RADS score OR Global ISUP score = 3 with MRI PI-RADS score = 5
• Candidate for radical prostatectomy
• Clinical prostate MRI not older than 3 months at screening
• ECOG performance status score of 0 or 1
• Able to receive Darolutamide for 90-120 days
• Signed informed consent form
• Willingness to use contraception if sexually active

Exclusion Criteria:

• Metastatic (M1) or node-positive (N2) disease
• Prior treatment with androgen receptor antagonists
• Prior treatment with gonadotropin-releasing hormone (GnRH)
• History of prior systemic or local therapy for prostate cancer (including radiation and focal therapy)
• Major surgery <4 weeks prior to inclusion

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Condition: Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT07395804

Sponsor: Bayer

Phase:

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Male patients aged ≥ 18 years
• Diagnosis of mHSPC with histological or cytological evidence for adenocarcinoma of prostate
• Metastatic disease by conventional or new generation imaging
• Physician decision to initiate treatment with Darolutamide+ADT was made as per investigator's routine treatment practice prior to enrollment in the study
• Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).

Exclusion Criteria:

• Darolutamide treatment started more than 30 days prior to study enrollment
• ADT treatment started more than 12 weeks before the start of treatment with darolutamide plus ADT
• Hypersensitivity to darolutamide or any other excipient
• Other prior systemic hormonal or anti-cancer treatment for mHSPC
• Participation in an investigational program for prostate cancer with interventions outside of routine clinical practice

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Condition: Prostate Adenocarcinoma, Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage II Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07468903

Sponsor: Jonsson Comprehensive Cancer Center

Eligibility:

• Age: minimum 40 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Histologically confirmed diagnosis of prostate adenocarcinoma within 90 days prior to registration via systematic biopsy
• Multiparametric MRI (mp-MRI) confirmed lesion(s)
• No distant or locally advanced disease on standard staging exams as indicated
• Bone scan and abdominopelvic computed tomography (CT)/MRI OR
• PSMA PET
• Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment
• Age ≥ 40

Exclusion Criteria:

• Radiographic nodal or distant metastatic disease
• Lesion(s) comprising > 40% of total prostate volume
• Prior radiotherapy to the pelvis
• Gleason score > 6 disease outside intended gross target volume (GTV)/target region(s)

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Condition: Metastatic Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07529717

Sponsor: AstraZeneca

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum 100 Years
• Gender: Male

Inclusion Criteria:

• Histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer
• Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L)
• PSA value at screening should be ≥ 1ng/mL
• Evidence of disease progression within 6 months prior to screening
• Part A Participants should have received at least 2 prior approved systemic therapies for prostate cancer with at least one androgen receptor pathway inhibitor and at least one taxane regimen if amenable
• Part B Participants should have received an androgen receptor pathway inhibitor for metastatic hormone sensitive prostate cancer or metastatic castration resistant prostate cancer (mCRPC). No prior taxane treatment for mCRPC is allowed for Module 1 and 2 Part B patients
• Adequate organ function
• Body weight ≥ 35 kg

Exclusion Criteria:

• Any clinically relevant cardiac abnormalities such as QT prolongation or uncontrolled cardiac arrythmias
• All prior treatment-related adverse events must have resolved to Grade ≤ 2
• History of Grade ≥ 3 cytokine release syndrome or Grade ≥ 2 immune effector cell-associated neurotoxicity syndrome with prior therapy
• Active or prior documented autoimmune or inflammatory disorders within the past 3 years
• Prior exposure to any STEAP2 targeted agents or TCEs for prostate cancer

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Condition: Metastatic Castration-resistant Prostate Cancer (mCRPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07493512

Sponsor: Amgen

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
• mCRPC with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scintigraphy imaging obtained within 28 days prior to enrollment.
• Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
• Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL.
• Soft tissue progression defined as an increase ≥ 20% and an absolute increase of ≥ 5 mm in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions.
• Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scintigraphy (as per the 2+2 PCWG3 criteria).
• Prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L).
• Prior progression on at least one androgen receptor pathway inhibitor (androgen receptor pathway inhibitor [ARPI], enzalutamide, abiraterone, apalutamide, darolutamide).
• Prior treatment with only one taxane therapy in the mCRPC setting. Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also received one, and only one, taxane therapy in the mCRPC setting.

Exclusion Criteria:

• History of central nervous system metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible.
• History of allergic reactions or acute hypersensitivity reactions to the components of the trial therapies and their analogs. Participants with known contraindications to high-dose corticosteroids are also excluded.
• History of malignancy that is expected to alter life expectancy or may interfere with disease assessments. Participants with prior history of malignancy that have been adequately treated and who have been disease-free for >3 years are eligible, as are participants with adequately treated non-melanoma skin cancer or superficial bladder cancer.
• Active autoimmune disease that has required systemic treatment (except physiologic replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on trial.
• Known positive test for human immunodeficiency virus.
• Presence or history of viral hepatitis infection.
• Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of trial treatment with the following exceptions:
• Androgen-deprivation therapy with luteinizing hormone-releasing hormone/gonadotropin-releasing hormone (LHRH/GnRH) analogue (agonist/antagonist) is allowed.
• ARPIs (enzalutamide, abiraterone, apalutamide, darolutamide) require a minimum washout of 2 weeks prior to the first dose of xaluritamig.
• Prior prostate-specific membrane antigen (PSMA) radionuclide therapy cannot be given within 3 months prior to first dose of xaluritamig unless participant received <2 cycles of therapy, in which case participant cannot have received PSMA radionuclide therapy within 35 days prior to first dose.
• Any prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
• Any prior cluster of differentiation 3 (CD3)-directed therapy.
• Requirement for chronic systemic corticosteroid therapy (prednisone dose >10 mg/day or equivalent) or any other immunosuppressive therapies (including anti TNFα therapies).
• Participation on any other xaluritamig trial, regardless of whether xaluritamig was administered.

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Condition: Prostate Cancer, Prostate Cancer (Adenocarcinoma)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07541911

Sponsor: University College, London

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Patients diagnosed with clinically significant operable cT2-T3a N0 M0 PC.
• Medically fit to undergo RARP.
• Scheduled for robot-assisted RARP with a recommendation against intrafascial nerve sparing on at least 1 side based on multidisciplinary meetings informed by MRI, biopsy result and clinical factors.
• Ability to read English sufficiently to understand PIS and able to give informed consent.

Exclusion Criteria:

• Patients who received neo-adjuvant ADT.
• MRI informed very low likelihood for extra prostatic extension in the proximity of NVB (Based on EPE Likert 1 score or tumour away from the posterolateral areas of the prostate)
• MRI informed high likelihood for extra prostatic extension in the proximity of NVB (based on Likert 5 score or bulging tumour on MRI T2 images)
• Patients in whom preoperative imaging shows rectal involvement or seminal vesicle invasion in which nerve-sparing is deemed not feasible due to oncological safety concerns.
• Patients who received previous treatment for prostate cancer: External beam radiotherapy, brachytherapy, focal therapy, chemotherapy.

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Condition: Radical Prostatectomy, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction Due to Arterial Insufficiency, Robotic Radical Prostatectomy

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT07597798

Sponsor: University College, London

Phase:

Eligibility:

• Age: minimum 18 Years maximum 79 Years
• Gender: Male

Inclusion Criteria:

• Men diagnosed with cT2-T3a N0 M0 PCa aged between 18 and 79 from all ethnic backgrounds.
• Patients who underwent a prostate mpMRI before prostate biopsy.
• Medically fit to undergo RARP.
• Diagnostic quality prostate biopsies concordant with a diagnostic quality prostate mpMRI adequate to provide a surgical plan.
• Scheduled for RARP with a recommendation of NVB spare based on multidisciplinary meetings informed by mpMRI, biopsy result and clinical factors.
• Sexually active men with no to mild ED at baseline based on IIEF-EFD (>=24) questionnaire.
• Preference to preserve erectile function for sexual intercourse.
• Ability to read English sufficiently to understand PIS and able to give informed consent.

Exclusion Criteria:

• Established moderate/ severe ED (IIEF-EFD <24)
• Patients who received neo-adjuvant androgen deprivation therapy.
• Patients with previous surgery for benign prostatic enlargement
• Patients who received previous treatment for prostate cancer: External beam radiotherapy, brachytherapy, focal therapy, chemotherapy.
• Previous pelvic or penile fracture
• Previous surgery for ED
• Poor quality prostate mpMRI or biparametric MRI (no contrast)
• Established vascular disease (ischaemic heart disease, cerebrovascular disease, peripheral vascular disease)

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Condition: High-Risk Localized Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07450599

Sponsor: Bayer

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Participants must be 18 years or older at the time of signing the informed consent.
• Darolutamide-naïve participants who are with localized prostate adenocarcinoma who plan to receive radical prostatectomy (RP) and defined as high risk with National Comprehensive Cancer Network (NCCN) criteria (version 1.2025).
• No evidence of distant metastasis based on computed tomography (CT), magnetic resonance imaging (MRI), and whole body bone scan (WBBS) within 42 days prior to start of study treatment.
• Candidate for RP with pelvic lymph node dissection (PLND) or extended PLND (ePLND) as per the investigator.
• Participants must have at least one of the following features according to NCCN definition of high-risk:
• Biopsy Gleason score ≥8, and/or
• Prostate-specific antigen (PSA) >20 ng/mL measured during Screening and prior to randomization, or
• Clinical stage ≥ T3a.
• Participants with pelvic lymph node involvement (N1) can be included.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Exclusion Criteria:

• Prostate cancer with known neuroendocrine (NE) differentiation or small cell features.
• Evidence of metastatic disease. Minimum imaging requirements to exclude metastatic disease are diagnostic quality imaging of the chest, pelvis, and the abdomen (CT or MRI with intravenous [IV] contrast), and WBBS. Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
• Intolerant to darolutamide or androgen deprivation therapy (ADT) treatment.
• History of
• Loss of consciousness or transient ischemic attack or stroke within 6 months prior to randomization, or
• Significant cardiovascular disease within 6 months prior to randomization.
• Any contraindications for RP.
• Uncontrolled or treatment-resistant hypertension.
• History of another malignancy within 5 years prior to randomization.

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Condition: Prostate Cancer, Localized Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07455903

Sponsor: Baptist Health South Florida

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study.
• Males aged ≥18 years.
• ECOG performance status ≤ 1
• Histologically confirmed adenocarcinoma of the prostate in a patient amenable to radical prostatectomy
• Pathologically proven prostate adenocarcinoma with ≥ 1 High-risk feature based on NCCN guidelines. 1. cT3-cT4 2. International Society of Urological Pathology (ISUP) Grade group 4 (Gleason score 8) or grade group 5 (Gleason score 9-10) 3. PSA >20 ng/mL
• Clinically negative lymph nodes as established by PSMA PET/CT imaging. Patients who are node positive by PSMA PET/CT (e.g., N1), but whose nodes do not meet traditional size criteria for positivity (e.g., they measure ≥ 10mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 and would be eligible for this study.
• Patient is willing to use barrier-method of contraception along with another effective contraceptive method if engaged in sexual activity with a pregnant person or individual of childbearing potential (until 1 week after completing 18F-flotufolastat PSMA PET/CT Scans.
• Clinical laboratory values during screening: 1. Hemoglobin ≥ 10.0 g/dL 2. Absolute neutrophil count (ANC) ≥ 1.8 × 10⁹/L 3. Platelets ≥ 100 × 10⁹/L

Exclusion Criteria:

• Known allergies, hypersensitivity, or intolerance to 18F-flotufolastat.
• Unable to receive androgen deprivation therapy.
• Prostate cancer with significant neuroendocrine or other rare variant pathology
• Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the bifurcation of the common iliac arteries on PSMA PET/CT
• Renal impairment (glomerular filtration rate <30 mL/min)
• History of prior radiation therapy for prostate cancer
• Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, clinically significant ventricular arrhythmias, or New York Heart Association Class II to IV heart disease.
• Uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or untreated HIV infection.
• Other malignancies other than prostate cancer in the past 5 years a. Cured basal cell or squamous cell skin cancers can be enrolled.
• Severe or uncontrolled concurrent infections are not eligible.
• Treated with concomitant cytotoxic cancer therapy for any other primary site.
• Patients who are unable to complete the study requirements of 2nd PSMA imaging or surgery for the primary endpoints.
• Any condition that, in the opinion of the investigator, would preclude participation in this study.

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07580196

Sponsor: University of Turin, Italy

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Male patients aged 18 years or older
• Histologically confirmed unilateral high-risk localized prostate cancer, defined by at least one of the following: ISUP Grade Group 4 or 5; suspicion of at least cT3a disease on multiparametric MRI and/or PSMA PET; or PSA greater than or equal to 20 ng/mL with a unilateral index lesion
• Unilateral features of the index lesion defined by biopsy, multiparametric MRI, and PSMA PET
• No PSMA PET-positive pelvic lymph nodes contralateral to the dominant side of the prostate cancer
• No significant contralateral PSMA uptake on the non-dominant side, defined as lesions with PRIMARY score 3 to 5
• No contralateral index lesion on multiparametric MRI subsequently confirmed by prostate biopsy
• No high-risk histology on the side contralateral to the dominant lesion, including ISUP Grade Group greater than 3 or unconventional prostate cancer histology
• No frank extracapsular invasion or seminal vesicle invasion on the contralateral side
• Up to two positive systematic cores with unfavorable intermediate-risk disease or up to four with favorable intermediate-risk disease are allowed on the contralateral side
• A maximum of two pelvic PSMA-positive lymph nodes allowed on the dominant side
• Clinically localized disease, defined as less than cT4 on multiparametric MRI and no distant metastases, including no retroperitoneal lymph nodes on PSMA PET
• Life expectancy greater than 10 years according to physician judgment
• Scheduled for robot-assisted radical prostatectomy and fit for surgery
• Written informed consent provided

Exclusion Criteria:

• Any prostate cancer treatment prior to prostatectomy, including androgen deprivation therapy, neoadjuvant chemotherapy, radiotherapy, or focal ablative therapy
• Prior active treatment for prostate cancer
• Contralateral ISUP Grade Group 4 to 5 prostate cancer
• Contralateral ISUP Grade Group 2 in more than 4 positive cores or ISUP Grade Group 3 in more than 2 positive cores
• Contralateral cT3 disease on multiparametric MRI
• N1 or M1 disease on PSMA PET or multiparametric MRI, except for up to two positive pelvic lymph nodes on the dominant side
• No systematic prostate biopsies performed, with a minimum of 10 cores, and targeted biopsies when a target lesion is present
• Other active malignancy
• Contraindication to multiparametric MRI and/or PSMA PET
• Inability to provide written informed consent
• Age younger than 18 years
• ASA score greater than 3
• Any contraindication to pelvic lymph node dissection
• Severe psychiatric disease
• Inadequate hematologic and/or coagulation function
• Active infection
• Any other serious medical, psychiatric, psychological, familial, or geographic condition that, in the judgment of the investigator, may interfere with staging, treatment, follow-up, compliance, or increase treatment-related risk
• Patients with prior malignancy treated with curative intent are eligible only with mandatory approval by the local multidisciplinary tumor board

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Condition: Castration Resistant Metastatic Prostate Cancer, Prostate Cancer, mCRPC (Metastatic Castration-resistant Prostate Cancer), mCRPC, B7H3

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07581184

Sponsor: Aktis Oncology, Inc.

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Age ≥ 18 years
• Histologic or cytologic confirmation of prostatic adenocarcinoma
• ECOG Performance Status of 0 or 1
• Adequate end-organ function
• Ability to give informed consent and comply with study requirements
• Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids
• Castrate levels of serum testosterone (< 50 ng/dL)
• Documented disease progression on most recent prior line of therapy, either by PSA or imaging-based progression
• Cohort B: Received 2 or more prior doses of 177Lu-PSMA-617 (PLUVICTO)

Exclusion Criteria:

• Prior treatment with more than 2 Androgen receptor pathway inhibitors (ARPIs) and/or more than 1 taxane-based therapy in the mCRPC setting
• Prior treatment with a targeted radiotherapy o Exception: Cohort B is required to have had at least 2 prior doses of 177Lu-PSMA-617 (PLUVICTO)
• Prior treatment with a B7-H3 targeted therapy
• Received an investigational agent within the previous 28 days
• Impaired cardiac function or clinically significant cardiac disease
• Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity

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Condition: Prostate Cancer, Hot Flashes

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07535541

Sponsor: University of Virginia

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male (biologic sex), aged ≥18 years of age
4. Diagnosis of prostate cancer
5. Must be receiving active treatment with ADT at the time of enrollment a. ADT is defined as any medical or surgical intervention intended to lower the serum testosterone to <50 mg/dL for the purpose of treating prostate cancer
6. Evidence of castrate level testosterone by either of the following:
7. A documented serum testosterone level of <50 ng/dL at any time point since initiation of ADT or
8. A documented decrease in PSA following initiation of ADT and no evidence of PSA progression per PCWG3 criteria (PSA progression defined as a rise in PSA of ≥25% from PSA nadir and absolute increase of ≥1 ng/mL confirmed by a second measurement at least 3 weeks later)
9. Duration of ADT expected to extend for a minimum of 4 weeks from time of study enrollment
10. Report experiencing VMS that began after initiation of ADT and occur with a minimum frequency of once per day
11. Own a smartphone with Bluetooth 5 compatibility and be willing to use cellular data and/or Wi-Fi on their smartphone. Participants must agree to download the Empatica Care app on their smartphone.
12. iPhone 8 or higher with iOS 16.0 or higher
13. Android devices version 12, 12.1, 13, 14, 15, or higher
14. Ability to read, speak, and understand English
15. ECOG performance status of 0, 1, or 2

Exclusion Criteria:

1. Wrist circumference less than 95 mm or greater than 222 mm
2. Known allergic reactions to components of the EmbracePlus smart watch, specifically any skin allergy to silicone
3. Presence of VMS prior to initiation of ADT, regardless of severity or duration
4. Active febrile illness (temperature >38°C) or on active treatment for febrile illness
5. Inability to press button on smart watch crown
6. Those receiving any experimental therapy for treatment of their prostate cancer (other standard of care prostate cancer therapies are permitted)
7. Evidence of progression of prostate cancer as defined by PCWG3 criteria

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Condition: Metastatic Castration-resistant Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07414940

Sponsor: University College, London

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. Age ≥ 18 years at time of providing informed consent.
2. Histologically- or cytologically-confirmed diagnosis of prostate adenocarcinoma, which may include small cell or neuroendocrine features.
3. Castration-resistant prostate cancer, defined as a rising PSA despite surgical castration or ongoing medical castration, with serum testosterone ≤ 0.5ng/mL or <1.7 nmol/L.
4. Progressive mCRPC with rising PSA level, as defined by PCWG3 criteria, or by radiological progression, and must demonstrate a sequence of rising values above baseline at a minimum of 1-week intervals and PSA > 1 ng/mL.
5. PSMA-avid disease on screening PSMA-PET-CT scan
6. Prior treatment with at least one second-generation androgen receptor pathway inhibitor (ARPI)
7. Prior treatment with at least one but no more than two lines of taxane therapy for prostate cancer, or been deemed ineligible or refused taxane therapy on consultation with their treating physician.
8. At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation of trial treatment. Anti-cancer treatment includes ARPIs and PARP inhibitors but excludes ADT (e.g. luteinising hormone releasing hormone (LHRH) analogue or gonadotropin-releasing hormone treatment), which should be continued. Prednisone up to 10 mg daily (or equivalent) is also permitted.
9. Prior treatment with 177Lu-PSMA-targeted radiopharmaceutical therapy (e.g. 177Lu-PSMA-617, 177Lu PSMA-I&T) up to a maximum of 6 cycles and with response to therapy as judged by the treating physician. Exception: in Phase I, the first 3 participants treated at each dose level may be 177Lu-PSMA naïve Note: last treatment with 177Lu-PSMA must be more than 10 weeks prior to study enrolment.
10. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
11. Estimated life expectancy > 12 weeks.
12. Grade ≤ 1 xerostomia symptoms at time of trial enrolment.
13. Adequate bone marrow, renal, and hepatic function
14. Resolution of all previous treatment-related toxicities to CTCAE v5.0 Grade ≤ 1, except for chemotherapy-induced alopecia, Grade 2 peripheral neuropathy, and Grade 2 urinary frequency, which are permitted.
15. Adequate contraception for participants and their partners.
16. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
2. Active metastatic central nervous system (CNS) disease, including leptomeningeal disease.
3. Receipt of 177Lu-PSMA treatment within 10 weeks of trial enrolment.
4. Prior radiotherapeutic treatment for metastatic prostate cancer (e.g. Radium-223) with the exception of 177Lu-PSMA. Note: prior radiotherapeutic treatment for other cancers is permitted (e.g. radioactive iodine for thyroid cancer).
5. Receipt of transfused blood products or erythropoietin stimulating agents within 4 weeks of trial enrolment.
6. Major surgery within 12 weeks of trial enrolment.
7. Other current malignancy, or malignancy diagnosed/relapsed within the past 5 years (other than non melanomatous skin cancer, stage 0 melanoma in situ, or non-muscle invasive bladder cancer that has undergone curative intent therapy).
8. Sjogren's disease or any other medical conditions that in the judgement of the investigator puts the participant at increased risk of xerostomia.
9. Single kidney, renal transplant or any nephrotoxic condition or concomitant therapy that in the judgement of the investigator could put the participant at risk of unacceptable renal toxicity during the trial.
10. Severe urinary incontinence or any other conditions that in the judgement of the investigator would preclude safe disposal of radioactive urine.
11. Any structural kidney/renal tract disease that in the judgement of the investigator could affect excretion of the trial agent (e.g. hydronephrosis), unless addressed with intervention (e.g. ureteric stent insertion with normalisation of renal function).
12. Clinically significant abnormalities on a single 12-lead electrocardiogram (ECG) during screening evaluation.
13. Concurrent serious conditions that in the judgement of the investigator would pose a safety risk or impair trial participation.
14. Radiation therapy within 2 weeks before trial enrolment.
15. Hypersensitivity to the investigational product or any of its constituents.
16. Current participation in another trial with ongoing receipt of an investigational agent.
17. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule, or that would pose a risk to the participant's safety.

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Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07572760

Sponsor: University of Alicante

Eligibility:

• Age: minimum 50 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Histopathologically confirmed diagnosis of prostate adenocarcinoma. • Metastatic hormone-sensitive prostate cancer (mHSPC), defined as:
• Presence of metastases at initial diagnosis (synchronous mHSPC), or
• Development of metastatic disease following prior treatment with curative intent (surgery and/or radiotherapy) (metachronous mHSPC).
• Evidence of progression to castration-resistant prostate cancer (CRPC).
• Ongoing treatment with a doublet regimen consisting of standard androgen deprivation therapy (ADT) in combination with an androgen receptor signaling inhibitor (ARSI), initiated prior to study enrollment.
• Receipt of bone-protective therapy, including calcium and vitamin D supplementation in combination with bisphosphonates.
• Presence of metastatic involvement limited to bone and/or lymph nodes.
• Functionally independent in activities of daily living.

Exclusion Criteria:

• Evidence of visceral metastatic disease.
• Current or prior treatment with a triplet regimen that includes chemotherapy.
• History of pathological fracture.

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Condition: Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07504835

Sponsor: OHSU Knight Cancer Institute

Eligibility:

• Age: minimum 65 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Age 65 years of age or older.
• Diagnosed with histologically confirmed prostate cancer.
• Completed surgery, chemotherapy, radiation and/or systemic treatment (other than ADT) for cancer > 3 months ago.
• Experiencing cancer loneliness.
• Able to ambulate independently; reliance on assistive devices other than a wheelchair is allowed.
• Willing to be randomized into any of the three study arms and attend 80% or more of planned exercise sessions.
• Home internet sufficient for videoconferencing.

Exclusion Criteria:

• Participating in regular group exercise and/or structured resistance training with other cancer survivors (> 1 exercise partner or groups of 3 or more).
• Health or medical condition that affects movement or neurological disorder, or medication that contraindicates participation in live remote resistance exercise.
• Cognitive difficulties that preclude answering the survey questions, participating in the intervention, or giving informed consent.
• Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English.

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