Prostate Cancer

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

APA-RAP PCR2041: A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases 

Phase: 2
Study Product: Apalutamide with ADT post radical prostatectomy (RP)
Estimated Study Completion Date: December 11, 2023
ClinicalTrials.gov Identifier: NCT04523207

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

MCSPC

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

nmCRPC or MCRPC

DaroAct 20609: Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)

Phase: 2b
Study Product: Darolutamide vs. Enzalutamide
Estimated Study Completion Date: December 31, 2022
ClinicalTrials.gov Identifier: NCT04157088

mCRPC

Treatment naïve

TALAPRO-2: Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

Phase: 3
Study Product: Talazoparib with Enzalutamide vs. Placebo with Enzalutamide
Estimated Study Completion Date: November 25, 2024
ClinicalTrials.gov Identifier: NCT03395197

Post Abi or Enza 

KEYNOTE-641: Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer

Phase: 3
Study Product: Pembrolizumab with Enzalutamide vs. Placebo with Enzalutamide
Estimated Study Completion Date: November 12, 2023
ClinicalTrials.gov Identifier: NCT03834493

Progressing on NHA (Abi or Enza)

ORIC-101-02: An Open-Label Phase 1b Study of ORIC-101 in Combination With Enzalutamide in Patients With Metastatic Prostate Cancer Progressing on Enzalutamide

Phase: 1b
Study Product: ORIC-101 vs. Enzalutamide
Estimated Study Completion Date: December 2022
ClinicalTrials.gov Identifier: NCT04033328

PLX124-04: A Multicenter, Open-Label, Parallel, Phase 1b/2a Study of PLX2853 in Combination with Abiraterone Acetate and Prednisone and Phase 1b/2a Study of PLX2853 in Combination with Olaparib in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Phase: 1b/2a
Study Product: PLX2853 + Abiraterone Acetate & Prednisone versus PLX2853 + Olaparib
Estimated Study Completion Date: March 30, 2023
ClinicalTrials.gov Identifier: NCT04556617

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: Abiraterone + ARV-110
Estimated Study Completion Date: TBD
ClinicalTrials.gov Identifier: Not yet listed

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

Olaparib PLX124-04: A Multicenter, Open-Label, Parallel, Phase 1b/2a Study of PLX2853 in Combination with Abiraterone Acetate and Prednisone and Phase 1b/2a Study of PLX2853 in Combination with Olaparib in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Phase: 1b/2a
Study Product: PLX2853 + Abiraterone Acetate & Prednisone versus PLX2853 + Olaparib
Estimated Study Completion Date: March 30, 2023
ClinicalTrials.gov Identifier: NCT04556617

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