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Prostate CancerPSMA (prostate-specific membrane antigen) Clinical Trials

30 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

Phase 2
NCT05413850Anti-tumour Activity of (177Lu) rhPSMA-10.1 InjectionPhase 1/Phase 24 US sitesNCT07285694AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)Phase 1/Phase 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 sitesNCT06288113Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA TrialPhase 21 US siteNCT07258407A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate CancerPhase 1/Phase 21 US siteNCT06392295PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate CancerPhase 21 US siteNCT06200103Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate CancerPhase 21 US siteNCT05766371Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate CancerPhase 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 siteNCT06145633Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate CancerPhase 21 US siteNCT06574880STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate CancerPhase 1/Phase 21 US siteNCT06096870Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering TherapyPhase 21 US siteNCT06972628Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617Phase 21 US site
Phase 1
Phase 4 / Other
7 international trials (no US sites)
NCT07363486Sequential Study of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate CancerPhase 1/Phase 2NCT05521412EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&TPhase 1/Phase 2NCT06970119A Multicenter, Open-label, Non-randomized Phase I/IIa Clinical Trial to Evaluate INR102 Injection in Patients With Prostate CancerPhase 1/Phase 2NCT05893381Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST)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 2NCT06756334Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in PCa Diagnosis, Recurrence, and MetastasisEarly Phase 1NCT05656573CART-PSMA Cells for Advanced Prostate CancerPhase 1
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