mCRPC

13

Review clinical trials related to mCRPC. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

A Phase 3 Study of [177Lu]Ludotadipep for Metastatic Castration-Resistant Prostate Cancer

Primary Efficacy Endpoint \- Radiographic Progression-Free Survival (rPFS): rPFS is defined as the time from randomization to radiographic disease progression (PD), as assessed by Blinded Independent Central Review (BICR) according to PCWG3-modified RECIST version 1.1, or death from any cause, whichever occurs first. rPFS will be analyzed using the Kaplan-Meier method. The median survival time and corresponding two-sided 95% confidence intervals (CIs) will be estimated for both the investigational and control arms, and Kaplan-Meier curves will be presented. A comparison between the investigational and control arms will be performed using a stratified Cox proportional hazards regression model. The model will be adjusted for the following stratification factors: nomogram score (≥178 vs \<178), ECOG Performance Status (0 or 1 vs 2), prior use of cabazitaxel before randomization (yes vs no), and receipt of best supportive care alone (yes vs no). The p-value will be reported. Ties in event times will be handled using the Efron method. The hazard ratio (HR) of the investigational arm relative to the control arm and its corresponding two-sided 95% confidence interval will be provided.

Participants needed: 114
Trial details
Phase: Phase 3Age: 19+Biological sex: MaleType: InterventionalSponsor: FutureChemUpdated: Oct 1, 2026Locations: 8
Eligibility criteria

Adult male aged ≥19 years at the time of written informed consent. [+15]

PSMA-targeted radioligand therapy [+12]

Status: Not yet recruiting

REGN21353 Alone or in Combination With Nezastomig for Metastatic Castration-Resistant Prostate Cancer in Adult Participants

This study will test an experimental Regeneron drug called REGN21353 ("study drug") to see if it can help treat previously treated prostate cancer that has spread (also called metastatic castration-resistant prostate cancer or mCRPC). Some participants may get additional experimental drugs in combination with REGN21353. These additional drugs are nezastomig and sarilumab. "Experimental" means that the drugs are being tested and have not been approved for use in prostate cancer by a country's national health agency that gives approval for new medicines to be prescribed. The study is looking at: * What is the best dose of REGN21353 alone and together with nezastomig for treating prostate cancer * What side effects REGN21353 alone and together with nezastomig might cause * How well REGN21353 alone and together with nezastomig works * How much REGN21353 alone and together with nezastomig is in the blood at different times * If the body reacts to REGN21353 alone or together with nezastomig, in a way that may cause them to not work as well * How REGN21353 alone and together with nezastomig could affect prostate cancer, which can help researchers understand why REGN21353 alone or together with nezastomig work better in some than others

Participants needed: 192
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: MaleType: InterventionalSponsor: Regeneron PharmaceuticalsUpdated: Sep 30, 2026
Eligibility criteria

Is male with histologically or cytologically confirmed adenocarcinoma of the pro... [+6]

Has not recovered (ie, grade ≤1 or baseline) from immune-mediated adverse event... [+9]

Status: Recruiting

A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

The goal of this clinical trial is to find out if FX-111 is safe enough to permit further studies in adult male participants with metastatic castration-resistant prostate cancer (mCRPC). It will also study the drug's pharmacokinetics (how the body breaks down FX-111) and how well FX-111 treats mCRPC. The main questions it aims to answer are: What are the side effects of FX-111? Does FX-111 work to reduce or prevent progression of mCRPC? The study doctor will oversee participants' treatment with FX-111 and ask about any side effects. Participants will take FX-111 every day by mouth and will have regular physical and laboratory examinations to check health and tumor status.

Participants needed: 60
Trial details
Phase: Phase 1Age: 18+Biological sex: MaleType: InterventionalSponsor: Flare Therapeutics Inc.Updated: Sep 24, 2026Locations: 10
Eligibility criteria

Confirmed adenocarcinoma of the prostate. [+8]

Predominance of small cell carcinoma of the prostate/neuroendocrine prostate can... [+8]

Status: Recruiting

A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer

This is a Phase 1b, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \[64Cu\]Cu-AKY-2519 and/or \[225Ac\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \[225Ac\]Ac-AKY-2519 in participants with metastatic castration-resistant prostate cancer (mCRPC) with and without prior exposure to 177Lu-PSMA-617 (PLUVICTO™).

Participants needed: 138
Trial details
Phase: Phase 1Age: 18+Biological sex: MaleType: InterventionalSponsor: Aktis Oncology, Inc.Updated: Sep 15, 2026Locations: 6
Eligibility criteria

Age ≥ 18 years [+8]

Prior treatment with more than 2 Androgen receptor pathway inhibitors (ARPIs) an... [+5]

Status: Recruiting

Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer

The goal of this phase 3 clinical trial is to determine the clinical effectiveness and cost effectiveness of using lower doses of Androgen Receptor Pathway Inhibitors (ARPI) to treat patients with prostate cancer that has spread (metastasized). The main questions it aims to answer are: 1. if overall survival for reduced dose ARPI is not worse than standard dose ARPI when treating patients with metastatic prostate cancer, and 2. that fatigue (extreme exhaustion) and not stopping ARPI permanently (due to adverse effects) are better than average with the reduced dose. Participants will: * Be randomised to take full dose (100%) of ARPI or half dose (50%) of ARPI. * Receive standard of care ADT. * Be on treatment for approximately 3 years according to standard of care. * Have clinic assessments and visits in clinic or remotely, as per their treating hospital's standard routine local practice in line with standard of care. Additional visits are not expected. * Complete quality of life questionnaires at week 0 (pre-treatment) and weeks 4, 16, 32, 48 and 64. * Keep a diary of their symptoms. Translational research samples will be collected as follows: * Blood samples at week 0 (pre-treatment) and weeks 24, 32, 48 and at disease progression. * Urine samples at week 0 (pre-treatment) and week 24 and at disease progression. * FFPE Tumour: Routinely collected diagnostic blocks. The duration of follow-up is approximately 3 years after the last patient is recruited (minimum follow-up is 3 years; maximum follow-up is approximately 6 years for the the first patient recruited) and the trial is expected to complete August 2032 (Last Patient Last Visit).

Participants needed: 1,500
Trial details
Phase: Phase 3Age: 18+Biological sex: MaleType: InterventionalSponsor: University College, LondonUpdated: Sep 4, 2026Locations: 1
Eligibility criteria

Adult males (male sex at birth) aged 18 years or older [+4]

Pathology other than adenocarcinoma consistent with small cell, ductal, sarcomat... [+8]

Status: Recruiting

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

Study K36-MCRPC-001 is the first in human clinical trial testing KTX-2001 alone and with darolutamide in men with metastatic castration-resistant prostate cancer. The study aims to assess whether the drug is safe, increasing doses alone and in combination with darolutamide, whether it is effective in treating metastatic castration-resistant prostate cancer, and measuring how the drug(s) behaves in the body.

Participants needed: 144
Trial details
Phase: Phase 1Age: 18+Biological sex: MaleType: InterventionalSponsor: K36 Therapeutics, Inc.Updated: Jul 9, 2026Locations: 13
Eligibility criteria

Age ≥18 years. [+8]

Presence of symptomatic or uncontrolled brain metastases unless adequately treat... [+17]

Status: Recruiting

Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection

To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.

Participants needed: 82
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: MaleType: InterventionalSponsor: Blue Earth Therapeutics LtdUpdated: May 14, 2026Locations: 21
Eligibility criteria

Male subjects, 18 years of age or older with histologically confirmed adenocarci... [+10]

Known hypersensitivity to the therapeutic or diagnostic IMP or any of its consti... [+21]

Status: Not yet recruiting

Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

This open-label, single-arm study evaluates the safety and preliminary efficacy of LC-K76 combined with Tislelizumab and ADT in 10 patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who progressed on prior therapies. Participants will receive oral LC-K76 and intravenous Tislelizumab for a 24-week treatment period.

Participants needed: 10
Trial details
Phase: Early Phase 1Age: 18-85Biological sex: MaleType: InterventionalSponsor: Shanghai Changzheng HospitalUpdated: Feb 5, 2026Locations: 1
Eligibility criteria

Male, aged 18 to 85 years. [+8]

Lack of pathological evidence for prostate cancer. [+10]

Status: Not yet recruiting

Study of TYK-00540 Combined With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer(mCRPC)

This study is to evaluate the safety, and preliminary antitumor activity of TYK-00540 combined with Enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy

Participants needed: 48
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: MaleType: InterventionalSponsor: TYK Medicines, IncUpdated: Aug 5, 2025Locations: 1
Eligibility criteria

Age ≥18 years. [+11]

Those who have previously received selective CDK2, CDK4 inhibitors, CDK4/6 inhib... [+23]

Status: Recruiting

A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer

This was a multicenter, open-label, phase I study to evaluate the safety, tolerability, radiation dosimetry and efficacy of \[177Lu\] Lu-PSMA-XT injection in patients with metastatic prostate cancer .

Participants needed: 36
Trial details
Phase: Phase 1Age: 18+Biological sex: MaleType: InterventionalSponsor: Jinming ZhangUpdated: Jul 31, 2025Locations: 3
Eligibility criteria

Patients must have the ability to understand and sign an approved informed conse... [+10]

Previous treatment with any of the following within 6 months of enrollment: Stro... [+6]

Status: Recruiting

Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer:a Phase II Study

This is an open-label,prospective,single-arm,phase 2 trial aims to evaluate the efficacy and safety of disitamab vedotin combined with abiraterone in patients with metastatic castration-resistant prostate cancer.

Participants needed: 20
Trial details
Phase: Phase 2Age: 18-75Biological sex: MaleType: InterventionalSponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUpdated: Jul 30, 2025Locations: 1
Eligibility criteria

Patients are able to understand and voluntarily sign the informed consent form (... [+17]

Patients who are known hypersensitivity to any component of disitamab vedotin or... [+20]

Status: Recruiting

The Radium-select Study

Radium-223 is an established radionuclide therapy for patients with metastatic castration resistant prostate cancer (mCRPC) and symptomatic bone metastasis. Patients are eligible for this treatment when they have mCRPC and bone metastases; limited extraskeletal lesions (local prostate, lymph nodes \<3 cm) on conventional contrast enhanced CT (ceCT) were allowed in the registration trial(1). Previous research revealed that extraskeletal disease on ceCT and bone scans correlates with a poor response. Meanwhile, 68Ga-PSMA-PET/CT emerged as more sensitive imaging strategy that increases the detection of extraskeletal prostate cancer metastases. It is unclear whether these extraskeletal lesions harbour any predictive value in the treatment of mCRPC patients with Radium-223.

Participants needed: 60
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: The Netherlands Cancer InstituteUpdated: Jul 8, 2025Locations: 5
Eligibility criteria

Histologically confirmed adenocarcinoma of the prostate. [+4]

Eastern Cooperative Oncology Group (ECOG) performance score >2 [+2]

Status: Recruiting

A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study evaluating the efficacy and safety of HC-1119 soft capsules versus placebo in mCRPC patients who have failed or become intolerant to the treatments with both abiraterone acetate and docetaxel, or who are not suitable for docetaxel treatment.

Participants needed: 417
Trial details
Phase: Phase 3Age: 18+Biological sex: MaleType: InterventionalSponsor: Hinova Pharmaceuticals Inc.Updated: Mar 12, 2025Locations: 1
Eligibility criteria

Males aged ≥18 years at screening and voluntary to participate in the study and... [+14]

Received any anti-prostate cancer treatment within 4 weeks before randomization,... [+15]