Cancer clinical trial database.
Every new trial and trial result from New in Oncology, our weekly research briefing, since the first issue on . Search by NCT number, drug, or cancer type.
All entries in prostate cancer
- New trial Spotlight
Prostate cancer
Phase 3 BNT324 (DB-1311) B7-H3–targeted topoisomerase I–payload ADC vs docetaxel in mCRPC.
This randomized, open-label Phase 3 BioNTech SE study compares BNT324 (also known as DB-1311) with docetaxel plus prednisone/prednisolone in men with progressive metastatic castration-resistant prostate cancer who…
NCT07365995 Registrational - New trial
Prostate cancer
Phase 1b xaluritamig (AMG 509) STEAP1×CD3 bispecific T‑cell engager in mCRPC.
This Phase 1b, open-label study from Amgen evaluates the safety (primary) and early activity of xaluritamig at the proposed regimen in adults with metastatic castration-resistant prostate cancer who have progressed…
NCT07493512 Exploratory - New trial
Prostate cancer
Pilot randomized study uses bicalutamide androgen-receptor inhibitor to modulate PSMA imaging signal
Washington University School of Medicine is running this randomized, open-label pilot study to test whether a short course of bicalutamide (a nonsteroidal androgen receptor inhibitor) alters PSMA expression enough to…
NCT07593079 Exploratory - Trial result
Prostate cancer
NanoKnife focal irreversible electroporation (IRE) shows no new failures at 2 years in intermediate-risk prostate cancer
PRESERVE (NCT04972097) is a prospective, single-arm pivotal FDA IDE study testing focal irreversible electroporation (IRE) with the NanoKnife System—an athermal, high-voltage electrical pulse ablation approach…
NCT04972097 - New trial Spotlight
Prostate cancer
Phase 1b/2 AZD9574 PARP1 inhibitor + AZD2265 (FPI-2265) PSMA-targeted actinium-225 alpha radioconjugate in mCRPC.
AstraZeneca’s open-label, multi-center platform study in metastatic prostate cancer includes Sub-study 1 for metastatic castration-resistant prostate cancer (mCRPC), testing AZD9574 (a PARP1-selective small-molecule…
NCT07590934 Exploratory - New trial
Prostate cancer
Phase 1b AKY-2519 B7-H3–targeted actinium-225 alpha radiopharmaceutical in mCRPC
Aktis Oncology’s BActinium-1 is a Phase 1b, multicenter, open-label study testing a B7-H3 (CD276)–targeted miniprotein radioconjugate: imaging with [64Cu]Cu-AKY-2519 PET to measure tumor uptake/dosimetry, and therapy…
NCT07581184 Exploratory - Trial result
Prostate cancer
PSMA PET/CT-guided sRT + field/ADT tailoring delivers 97% 5-year OS after post-RP recurrence
PSMA PET/CT is a prostate cancer–specific molecular imaging modality targeting PSMA to localize recurrence and guide salvage radiotherapy (sRT) after radical prostatectomy. In this retrospective analysis of 5…
- New trial
Prostate cancer
Phase 2/3 prostate SBRT trial tests focal DIL boost vs whole-gland boost (ionizing radiation)
This Phase 2/3 randomized study from the University of Nebraska compares two linear-accelerator–based stereotactic body radiotherapy (SBRT) dose-escalation strategies for treatment‑naïve localized prostate cancer.…
NCT07574489 Exploratory - New trial
Prostate cancer
Phase 2 TriAdeno (PSA/MUC1/brachyury Ad5 vaccine) + N-803 IL-15 superagonist in localized prostate cancer
This Phase 2 National Cancer Institute trial tests whether TriAdeno—an adenovirus type 5 (Ad5)–based therapeutic cancer vaccine expressing three tumor antigens (PSA, MUC1, and brachyury) to drive antigen-specific…
NCT07574541 Exploratory - New trial
Prostate cancer
Phase 1 INR731 trial tests oral investigational agent in mCRPC.
*No disclosed MOA. We do not include details of trials without this basic information.*
NCT07570979 First-in-human - Trial result Spotlight
Prostate cancer
Pembrolizumab (PD-1) + Lenvatinib (VEGFR/FGFR multikinase) posts 36% ORR in docetaxel-pretreated mCRPC (KEYNOTE-365)
Pembrolizumab is an anti–PD-1 monoclonal antibody, and lenvatinib is an oral anti-angiogenic multikinase inhibitor (VEGFR/FGFR/PDGFRα/RET/KIT); the combination was tested in KEYNOTE-365 Cohort E (Phase 1b/2) in…
NCT02861573 - Trial result
Prostate cancer
Abiraterone±enzalutamide (AR pathway inhibition) + ADT: early PSA ≤0.2ng/mL flags long-tail OS in STAMPEDE
This post-hoc landmark analysis pooled five randomized Phase 3 STAMPEDE comparisons in metastatic or very high-risk non-metastatic prostate adenocarcinoma (n=7129; recruited Oct 5, 2005–Sept 2, 2016) testing…
- Trial result
Prostate cancer
18F-flotufolastat (rhPSMA-7.3) PSMA-PET lowers bladder activity and lifts detection vs 18F-piflufolastat in low-PSA BCR
18F-piflufolastat (18F-DCFPyL; Pylarify) and 18F-flotufolastat (18F-rhPSMA-7.3; Posluma) are PSMA-targeted PET radiotracers for localizing recurrent prostate cancer; this prospective, multicentre, intra-patient…
NCT06604442 - Trial result Spotlight
Prostate cancer
Niraparib (PARP inhibitor) + abiraterone (CYP17 inhibitor) drives 38.6-mo rPFS in BRCA2+ Asian 1L mCRPC
Niraparib is an oral PARP inhibitor that exploits homologous recombination repair deficiency; here it was combined with abiraterone acetate + prednisone (AAP), an androgen biosynthesis (CYP17) inhibitor backbone, in…
NCT03748641 - Trial result
Prostate cancer
Cabazitaxel (microtubule-inhibitor taxane)–based “cabascore” stratifies mCRPC survival and predicts benefit vs 2nd ARPI
CABASTY post hoc (n=194) derived a 6-variable Cox-model “cabascore” (ECOG PS 0 vs 1–2, <2 vs ≥2 metastatic sites, PSA, LDH, ALP, hemoglobin) and split patients on cabazitaxel into favorable/intermediate/poor groups…
- New trial Spotlight
Prostate cancer
Phase 1 JANX014 PSMA-directed CD3 T cell engager (tumor-activated, double-masked)
Janux Therapeutics’ first-in-human Phase 1, open-label, multicenter trial evaluates JANX014, a prostate-specific membrane antigen (PSMA)–directed CD3 T cell engager designed with “double-masking” so it is…
NCT07545811 First-in-human - New trial
Prostate cancer
Phase 2 NanoKnife IRE non-thermal ablation boost vs focal radiation boost in SBRT
Memorial Sloan Kettering Cancer Center is running this randomized Phase 2 IRRADIANT study (NCT07548164) to test whether an irreversible electroporation (IRE) “boost” to the dominant intraprostatic lesion can match a…
NCT07548164 Exploratory - New trial
Prostate cancer
Phase 2 lutetium Lu 177 vipivotide tetraxetan PSMA-targeted radioligand with EBRT in high-risk localized prostate cancer.
This Phase 2, open-label, randomized study at Johns Hopkins (Sidney Kimmel Comprehensive Cancer Center) tests whether adding lutetium Lu 177 vipivotide tetraxetan (also known as 177Lu-PSMA-617; Pluvicto, from…
NCT07550517 Exploratory - New trial Spotlight
Prostate cancer
Phase 1/2 AZD8359 STEAP2-targeted CD8-guided T cell–engaging antibody in metastatic prostate cancer
This first-in-human, modular, open-label Phase 1/2 study (CRIUS-1) from AstraZeneca evaluates AZD8359, a T cell–engaging antibody designed to direct CD8 T cells toward STEAP2-expressing prostate cancer cells (STEAP2…
NCT07529717 First-in-human - New trial Spotlight
Prostate cancer
Phase Ib ^177Lu-PSMA-617 + liver-directed therapy for mCRPC with liver mets
UCSF evaluates Novartis’ PSMA-targeted Lu-177 radioligand therapy with site-directed treatment (TACE/ablation/Y-90 TARE) for mCRPC patients who’ve progressed on at least one AR-pathway inhibitor. PSMA RLT is a go-to…
NCT07145177 Exploratory - New trial
Prostate cancer
Phase Ib Elekta UNITY MR-Linac salvage SBRT + short ADT after prior EBRT
NYU Langone trials MR-guided SBRT with online adaptive replanning plus 4–6 months of ADT in biopsy-proven local recurrence post-EBRT. Salvage options (surgery/cryo/HDR/SBRT) can control disease but GU toxicity is a…
NCT07142967 Exploratory - New trial
Prostate cancer
Phase 1 study of KTX2001 NSD2 inhibitor with darolutamide androgen receptor inhibitor
Study K36-MCRPC-001 is a first-in-human Phase 1 dose escalation trial by K36 Therapeutics, Inc., evaluating KTX2001—an NSD2 histone methyltransferase inhibitor—alone and with darolutamide, an androgen receptor…
NCT07103018 First-in-human - New trial
Prostate cancer
Phase 1b study: JNJ-78278343 KLK2/CD3 bispecific and JNJ-95298177 PSMA ADC for prostate cancer.
This study by Janssen Research & Development evaluates combined dose finding and expansion using a Bayesian Optimal Interval design. It investigates JNJ-78278343, a T-cell redirecting KLK2/CD3 bispecific antibody,…
NCT07082920 Exploratory - New trial
Prostate cancer
Phase 2 ASP5541 Abiraterone Decanoate CYP17 Inhibitor in Advanced Prostate Cancer
This open-label multi-cohort trial by Astellas Pharma Global Development evaluates ASP5541, an intramuscular form of abiraterone decanoate (a CYP17 inhibitor), versus standard oral abiraterone acetate with…
NCT07005154 Exploratory - New trial Spotlight
Prostate cancer
Phase 2 Tarlatamab Study: DLL3/CD3 bispecific antibody in metastatic prostate cancer.
This Phase 2 trial evaluates tarlatamab, a DLL3 and CD3 directed bispecific monoclonal antibody, in patients with metastatic, DLL3‐positive prostate cancer that is refractory or relapsed after prior treatment (where…
NCT07111507 Exploratory - New trial Spotlight
Prostate cancer
Phase 1b pTVG-HP DNA vaccine and sasanlimab PD-1 inhibitor in oligometastatic prostate cancer
This study evaluates the combination of an investigational pTVG-HP DNA vaccine (targeting prostatic acid phosphatase) and sasanlimab, a PD-1 blocking monoclonal antibody, with radiation therapy in non-castrate,…
NCT07090148 Exploratory - Trial result
Prostate cancer
NanoKnife IRE Yields 71% 12‑mo Negative Biopsy While Preserving Function in Intermediate‑Risk Prostate Cancer
Irreversible electroporation (IRE) with the NanoKnife system—brief, high‑voltage pulses that perforate cell membranes without thermal damage—was evaluated in the single‑arm pivotal PRESERVE trial (NCT04972097). 121…
NCT04972097 - New trial
Prostate cancer
Phase II trial of JSB462 (AR inhibitor) with 177Lu vipivotide tetraxetan (PSMA-directed beta emitter)
This Phase II trial, sponsored by Novartis Pharmaceuticals, evaluates the efficacy and safety of JSB462 in combination with lutetium vipivotide tetraxetan versus lutetium vipivotide tetraxetan alone in adult men with…
NCT07047118 Exploratory - New trial
Prostate cancer
Phase 1/2 study of GSK5458514, a PSMA-targeting T cell engager for prostate cancer.
This study investigates the safety, tolerability, and dosing of GSK5458514 monotherapy in adults with metastatic castration-resistant prostate cancer across a two-part open-label design featuring dose escalation and…
NCT06990880 First-in-human - New trial
Prostate cancer
Phase I/II Trial of 225Ac-PSMA-R2, PSMA-targeted alpha therapy.
This open-label study by Novartis evaluates the safety, tolerability, and anti-tumor activity of 225Ac-PSMA-R2—a PSMA-targeted alpha emitter—in men with metastatic castration-resistant and hormone-sensitive prostate…
NCT05983198 First-in-human
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