Newly Diagnosed Prostate Cancer

Radical Prostatectomy

PROTEUS: A Study of ERLEADA (Apalutamide) in Participants With High‑Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Phase: 3
Study Product: Apalutamide with ADT vs. ADT with placebo
Estimated Study Completion Date: April 22, 2024
ClinicalTrials.gov Identifier: NCT03767244


PSA Relapse

MAP: Muscadine Plus (MPX) In Men With Prostate Cancer

Phase: 3
Study Product: Muscadine Plus
Estimated Study Completion Date: December 2021
ClinicalTrials.gov Identifier: NCT03535675


PROPELLA: Phase 1/2a, Open-label, Multicenter Study of Intramuscular PRL-02 Depot in Patients with Advanced Prostate Cancer

Phase: 1/2a
Study Product: abiraterone decanoate
Estimated Study Completion Date: December 31, 2023
ClinicalTrials.gov Identifier: NCT04729114


ADT Candidate

VERU: Open-Label, Proof-of-Concept and Dose Finding Phase 1b/2 Study of VERU-100 in Men With Advanced Prostate Cancer

Phase: 1b/2
Study Product: VERU-100
Estimated Study Completion Date: September 30, 2022
ClinicalTrials.gov Identifier: NCT04843319


MCSPC

CAPItello-281: A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Abiraterone Versus Placebo + Abiraterone as Treatment for Patients with DeNovo Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Characterised by PTEN deficiency (CAPItello-281)

Phase: 3
Study Product: Capivasertib plus abiraterone vs. placebo plus abiraterone
Estimated Study Completion Date: November 2025
ClinicalTrials.gov Identifier: NCT04493853


C3441052: Talapro-3: A Phase 3, Randomized, Double-Blind, Study of Talazoparib with Enzalutamide vs. placebo with Enzalutamide in men with DDR Gene Mutated Metastatic Castration Sensitive Prostate Cancer

Phase: 3
Study Product: talazoparib + enzalutamide vs. placebo + enzalutamide
Estimated Study Completion Date: April 10, 2027
ClinicalTrials.gov Identifier: NCT04821622


ARASEC: A Study to Learn How Well Darolutamide Administered Together with Androgen Deprivation Therapy (ADT) Works in Men with Metastatic Hormone-sensitive Prostate Cancer

Phase: 2
Study Product: Darolutamide + ADT 
Estimated Study Completion Date: February 5, 2026
ClinicalTrials.gov Identifier: NCT05059236


PSMAddition: An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Soc, Versus SoC Alone, in Adult Male Patients With mHSPC

Phase: 3
Study Product: 177Lu-PSMA-617 + SOC vs SOC Alone
Estimated Study Completion Date: December 18, 2025
ClinicalTrials.gov Identifier: NCT04720157


CSPC or CRPC

Prior to Abiraterone

Propella: Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients with Advanced Prostate Cancer

Phase: 1
Study Product: Abiraterone decanoate
Estimated Study Completion Date: December 31, 2023
ClinicalTrials.gov Identifier: NCT04729114


Responding to Abi, Apa, or Doce

MVT-601-049: A Phase 1, Three-Part, Open-Label, Parallel-Cohort Safety and Tolerability Study of Relugolix in Combination with Abiraterone Acetate Plus a Corticosteroid, Apalutamide, or Docetaxel with or without Prednisone in Men with Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

Phase: 1
Study Product: Abi + ADT ≥12 weeks prior to study start then switch to Abi + Relugolix OR Doce + ADT for at least 1 cycle prior to study start then switch to Doce + Relugolix; mCSPC or nmCRPC: Apa + ADT for at least 6 weeks prior to study start then switch to Apa + Relugolix
Estimated Study Completion Date: November 2023
ClinicalTrials.gov Identifier: NCT04666129


Progressing on Abiraterone Acetate

DisperSol: A PK and Dose Escalation and Expansion Study of DST-2970 in Patients With Prostate Cancer With Rising PSA on Treatment With Abiraterone Acetate

Phase: 1
Study Product: Abiraterone Acetate plus Prednisone 5Mg Tab plus DST-2970 (Abiraterone)
Estimated Study Completion Date: July 31, 2022
ClinicalTrials.gov Identifier: NCT04291664


 

mCRPC

Treatment naïve

ARES: A Phase 1b Study of EPI-7386, an Inhibitor of the Androgen Receptor N-terminal Domain, in Combination with Abiraterone Acetate plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)

Phase: 1b
Study Product: Group A: EPI-7386 + Abi; Group B: EPI-7386 + Apa
Estimated Study Completion Date: June 20, 2025
ClinicalTrials.gov Identifier: NCT05295927


Docetaxel Candidate

BMS CA209-7DX: Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer 

Phase: 3
Study Product: Nivolumab + Docetaxel Vs. Placebo + Docetaxel
Estimated Study Completion Date: July 6, 2024
ClinicalTrials.gov Identifier: NCT0410001


Progressing on ARTT

ARV-110: A Phase 1b Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-110 in Combination with Abiraterone in Patients with Metastatic Prostate Cancer

Phase: 1b
Study Product: ARV110 + Abi
Estimated Study Completion Date: November 2023
ClinicalTrials.gov Identifier: NCT05177042


Post Abi and/or Enza

AZ D5339C00001: A Modular Phase 2a Multicentre Open-Label Study to Investigate DNA-damage Response Agents (or Combinations) in Patients With Advanced Cancer Whose Tumours Contain Molecular Alterations (PLANETTE)

Phase: 2a
Study Product: Ceralasertib
Estimated Study Completion Date: June 8, 2023
ClinicalTrials.gov Identifier: NCT04564027


Post Abi, Enza, Apa, and/or Daro

FORMA 7051-ONC-101: A Phase 1 Study of FT-7051 in Men with Metastatic Castration-Resistant Prostate Cancer 

Phase: 1
Study Product: FT-7051
Estimated Study Completion Date: July 2023
ClinicalTrials.gov Identifier: NCT04575766


VERACITY V3011102: Randomized, Active-Controlled, Phase 3 Study of VERU-111 for the Treatment of Metastatic Castration-Resistant Prostate Cancer in Patients who have Failed Prior Treatment with at Least One Androgen Receptor Targeting Agent

Phase: 3
Study Product:  VERU-111 vs. alternate ARTT
Estimated Study Completion Date: August 19, 2024
ClinicalTrials.gov Identifier: NCT04844749


Post Doce

MK365: Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

Phase: 1b/2
Study Product: Cohort E: Pembro + Lenvatinib; Cohort F: t-NE-Pembro + Lenvatinib; Cohort G: Pembro + Vibostolimab; Cohort H: t-NE-Pembro + Vibostolimab
Estimated Study Completion Date: May 30, 2025
ClinicalTrials.gov Identifier: NCT02861573


Post 1L ARTT

C2321001: A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 In The Treatment Of Adult Patients With Castration Resistant Prostate Cancer (CRPC) 

Phase: 1
Study Product: PF-06821497
Estimated Study Completion Date: May 6, 2024
ClinicalTrials.gov Identifier: NCT03460977


PSMA-fore: A Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer

Phase: 3
Study Product: Lu-177 vs. Abi OR Enza
Estimated Study Completion Date: August 3, 2023
ClinicalTrials.gov Identifier: NCT04689828


SPLASH: A Phase 3, Open-Label, Randomized Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment

Phase: 3
Study Product: LU-177 + SOC (except chemo) vs. SOC
Estimated Study Completion Date: March 2028
ClinicalTrials.gov Identifier: NCT04647526


Disclaimer: We update this information regularly. However, what you read today may not be completely up to date. Please remember to talk to your healthcare providers first before making decisions about your plan of care.

Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study. To learn more about our trials, call Jennifer at (843) 449-1010 ext. 316 or email us by filling out the form below.