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Prostate CancerPSMA (prostate-specific membrane antigen) Clinical Trials

35 recruiting trials·Updated daily from ClinicalTrials.gov

PSMA (prostate-specific membrane antigen, encoded by FOLH1) is highly expressed on the surface of most prostate cancer cells and is the target of both PSMA PET imaging and PSMA-directed radioligand therapy. PSMA PET (68Ga gozetotide/Locametz, 18F-DCFPyL/Pylarify, among other approved agents) is used across metastatic prostate cancer for staging and recurrence work-up, and can select patients for PSMA-directed radioligand therapy. PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) is the eligibility basis for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, also known as Lu-177 PSMA-617), FDA-approved for patients previously treated with an androgen-receptor-pathway inhibitor (ARPI) — including, since the March 2025 label expansion, those considered appropriate to delay taxane chemotherapy. Trials investigate PSMA radioligands in earlier disease settings, alpha-emitter approaches such as actinium-225 PSMA, and combinations with AR-targeted agents or PARP inhibitors.

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Additional trials

More PSMA (prostate-specific membrane antigen) Prostate Cancer trials

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Phase 2
NCT06084338Randomized Phase II Trial of Targeted Radiation With no Castration for McrpcPhase 24 US sitesNCT06526299Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing DiseasePhase 23 US sitesNCT06990880A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate CancerPhase 1/Phase 22 US sitesNCT06392295PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate CancerPhase 21 US siteNCT05113537Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate CancerPhase 1/Phase 21 US siteNCT06738303Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate CancerPhase 21 US siteNCT06288113Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA TrialPhase 21 US siteNCT06216249Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)Phase 21 US siteNCT07258407A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate CancerPhase 1/Phase 21 US siteNCT05766371Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate CancerPhase 21 US siteNCT06145633Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate CancerPhase 21 US siteNCT06096870Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering TherapyPhase 21 US siteNCT06574880STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate CancerPhase 1/Phase 21 US siteNCT06972628Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617Phase 21 US site
Phase 1
8 international trials (no US sites)
NCT07689656A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate CancerPhase 1/Phase 2NCT07363486Sequential Study of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate CancerPhase 1/Phase 2NCT05893381Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST)Phase 2NCT05521412EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&TPhase 1/Phase 2NCT07056790Research on the Application of 68Ga-PSMA-CYC PET Imaging in the Diagnosis, Staging, and Restaging of Prostate CancerPhase 1/Phase 2NCT06970119A Multicenter, Open-label, Non-randomized Phase I/IIa Clinical Trial to Evaluate INR102 Injection in Patients With Prostate CancerPhase 1/Phase 2NCT05720130Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).Phase 1/Phase 2NCT05761366Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive TumorPhase 2
Related therapies

FDA-approved therapies for PSMA (prostate-specific membrane antigen) Prostate Cancer

Approved agents for this molecular target. Indication labels specify the approved patient population — some approvals apply to specific variants only.

PluvictoPSMA-targeted radioligand therapyPSMA-positive mCRPC after AR-pathway inhibitor therapy; includes post-taxane use and delay-taxane use (FDA Mar 2022; expanded Mar 2025)
Other Prostate Cancer biomarkers

Browse other molecular targets with active Prostate Cancer trials.

BRCA1BRCA2AR (Androgen Receptor)CDK12