Metastatic Castration-resistant Prostate Cancer

Oncology
31
Pipeline Programs
26
Companies
33
Clinical Trials
9 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
14
7
8
0
2
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
375%
Monoclonal Antibody
125%
+ 30 programs with unclassified modality

Competitive Landscape

26 companies ranked by most advanced pipeline stage

Bayer
BayerLEVERKUSEN, Germany
3 programs
1
1
1
Enzalutamide during Lead-in PeriodPhase 31 trial
Testosterone cypionatePhase 21 trial
ValemetostatPhase 1Small Molecule
Active Trials
NCT07142551Recruiting60Est. Jun 2034
NCT04237584Terminated23Est. Mar 2022
Sanofi
SanofiPARIS, France
2 programs
1
1
TaxoterePhase 31 trial
CabazitaxelPhase 11 trial
Active Trials
NCT01594918Completed25Est. Jun 2017
NCT02044354Unknown195Est. Apr 2018
Astellas
AstellasChina - Shenyang
2 programs
1
enzalutamidePhase 21 trial
MDV3100N/A1 trial
Active Trials
NCT01606982Approved For Marketing
NCT01650194Completed60Est. Jan 2018
Fusion Pharmaceuticals Inc.
2 programs
2
FPI-2265Phase 21 trial
FPI-2265Phase 21 trial
Active Trials
NCT06909825Active Not Recruiting85Est. Aug 2030
NCT06402331Recruiting100Est. Jan 2031
Alliance Pharmaceuticals
1 program
1
Lu-PSMAPhase 21 trial
Active Trials
NCT04419402Unknown162Est. Jan 2025
Coherus Oncology
Coherus OncologyCA - Redwood City
1 program
1
SRF617Phase 21 trial
Active Trials
NCT05177770Terminated16Est. Apr 2023
Arcus Biosciences
1 program
1
SRF617Phase 2
Xencor
XencorPASADENA, CA
1 program
1
vudalimab + carboplatin + cabazitaxelPhase 21 trial
Active Trials
NCT05005728CompletedEst. Jun 2025
CT
3 programs
1
2
TQB3201 tabletsPhase 1/21 trial
TQB3823 tabletsPhase 1/21 trial
TQB3720Phase 11 trial
Active Trials
NCT04853498UnknownEst. May 2023
NCT07172126Not Yet RecruitingEst. Dec 2028
NCT05405439TerminatedEst. Jul 2023
Amgen
AmgenTHOUSAND OAKS, CA
2 programs
1
1
AcapatamabPhase 1/2Monoclonal Antibody1 trial
AMG 340Phase 11 trial
Active Trials
NCT04740034Terminated42Est. Jun 2024
NCT04631601Terminated65Est. Oct 2023
Blue Earth Therapeutics
1 program
1
ActiniumPhase 1/21 trial
Active Trials
NCT07414940Not Yet RecruitingEst. Dec 2031
Corcept Therapeutics
Corcept TherapeuticsCA - Redwood City
1 program
1
CORT125281Phase 1/21 trial
Active Trials
NCT03437941Completed39Est. Jan 2023
OncoC4
OncoC4MD - Rockville
1 program
1
ONC-392 lowPhase 1/21 trial
Active Trials
NCT05682443Active Not RecruitingEst. Jun 2027
Laekna Therapeutics
Laekna TherapeuticsChina - Shanghai
1 program
1
Phase I and Phase II: LAE001/prednisone + afuresertibPhase 1/2Small Molecule1 trial
Active Trials
NCT04060394CompletedEst. Mar 2024
ARTBIO
ARTBIONorway - Oslo
1 program
1
212Pb-NG001Phase 11 trial
Active Trials
NCT05725070CompletedEst. Jul 2023
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
ABBV-969Phase 11 trial
Active Trials
NCT06318273Recruiting140Est. May 2027
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
1
AZD2287Phase 11 trial
Active Trials
NCT06879041Recruiting95Est. Apr 2029
Antares Therapeutics
1 program
1
Abiraterone AcetatePhase 11 trial
Active Trials
NCT04879589WithdrawnEst. Apr 2023
Regeneron
RegeneronTARRYTOWN, NY
1 program
1
BPX-601Phase 11 trial
Active Trials
NCT02744287Terminated52Est. Mar 2023
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
1
FT-7051Phase 11 trial
Active Trials
NCT04575766Terminated25Est. Nov 2022
City Therapeutics
City TherapeuticsMA - Cambridge
1 program
1
NKTR-214Phase 11 trial
Active Trials
NCT03835533Completed43Est. Oct 2022
Celldex Therapeutics
1 program
1
NKTR-214Phase 1
DS
Daiichi SankyoChina - Shanghai
1 program
1
ValemetostatPhase 1Small Molecule2 trials
Active Trials
NCT07244341Recruiting60Est. Nov 2029
NCT06244485Recruiting210Est. Nov 2028
Full-Life Technologies
Full-Life TechnologiesChina - Shanghai
1 program
1
[225Ac]Ac-FL-020Phase 11 trial
Active Trials
NCT06492122Recruiting50Est. Dec 2026
M&
Merck & Co.RAHWAY, NJ
1 program
FDG Positron emission tomographyN/A1 trial
Active Trials
NCT04000776CompletedEst. Jun 2023
Novartis
NovartisBASEL, Switzerland
1 program
Lutetium vipivotide tetraxetanN/A2 trials
Active Trials
NCT06514521Recruiting278Est. May 2028
NCT06517719Recruiting500Est. Feb 2028

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
BayerEnzalutamide during Lead-in Period
SanofiTaxotere
BayerTestosterone cypionate
Fusion Pharmaceuticals Inc.FPI-2265
Fusion Pharmaceuticals Inc.FPI-2265
Coherus OncologySRF617
Xencorvudalimab + carboplatin + cabazitaxel
Alliance PharmaceuticalsLu-PSMA
Astellasenzalutamide
Blue Earth TherapeuticsActinium
Chia Tai TianQing Pharmaceutical GroupTQB3201 tablets
OncoC4ONC-392 low
Chia Tai TianQing Pharmaceutical GroupTQB3823 tablets
AmgenAcapatamab
Laekna TherapeuticsPhase I and Phase II: LAE001/prednisone + afuresertib

Showing 15 of 32 trials with date data

Clinical Trials (33)

Total enrollment: 2,325 patients across 33 trials

NCT04237584BayerEnzalutamide during Lead-in Period

A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients

Start: Jun 2020Est. completion: Mar 202223 patients
Phase 3Terminated
NCT02044354SanofiTaxotere

Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer

Start: May 2014Est. completion: Apr 2018195 patients
Phase 3Unknown
NCT07142551BayerTestosterone cypionate

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

Start: Mar 2026Est. completion: Jun 203460 patients
Phase 2Recruiting
NCT06909825Fusion Pharmaceuticals Inc.FPI-2265

FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Start: Feb 2025Est. completion: Aug 203085 patients
Phase 2Active Not Recruiting
NCT06402331Fusion Pharmaceuticals Inc.FPI-2265

FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Start: Mar 2024Est. completion: Jan 2031100 patients
Phase 2Recruiting
NCT05177770Coherus OncologySRF617

Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer

Start: Jan 2022Est. completion: Apr 202316 patients
Phase 2Terminated
NCT05005728Xencorvudalimab + carboplatin + cabazitaxel

XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Start: Oct 2021Est. completion: Jun 2025
Phase 2Completed
NCT04419402Alliance PharmaceuticalsLu-PSMA

Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer

Start: Aug 2020Est. completion: Jan 2025162 patients
Phase 2Unknown
NCT01650194Astellasenzalutamide

A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients

Start: Jul 2012Est. completion: Jan 201860 patients
Phase 2Completed
NCT07414940Blue Earth TherapeuticsActinium

ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium

Start: Mar 2026Est. completion: Dec 2031
Phase 1/2Not Yet Recruiting
NCT07172126Chia Tai TianQing Pharmaceutical GroupTQB3201 tablets

Clinical Trial to Evaluate the Tolerance of TQB3201 Tablets

Start: Sep 2025Est. completion: Dec 2028
Phase 1/2Not Yet Recruiting
NCT05682443OncoC4ONC-392 low

ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC

Start: Dec 2023Est. completion: Jun 2027
Phase 1/2Active Not Recruiting
NCT05405439Chia Tai TianQing Pharmaceutical GroupTQB3823 tablets

To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer

Start: Aug 2022Est. completion: Jul 2023
Phase 1/2Terminated
NCT04631601AmgenAcapatamab

Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)

Start: Jan 2021Est. completion: Oct 202365 patients
Phase 1/2Terminated
NCT04060394Laekna TherapeuticsPhase I and Phase II: LAE001/prednisone + afuresertib

Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC

Start: Sep 2019Est. completion: Mar 2024
Phase 1/2Completed
NCT03437941Corcept TherapeuticsCORT125281

Study to Evaluate CORT125281 in Combination With Enzalutamide in Patients With mCRPC

Start: Dec 2017Est. completion: Jan 202339 patients
Phase 1/2Completed
NCT07244341Daiichi SankyoValemetostat

A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Start: Dec 2025Est. completion: Nov 202960 patients
Phase 1Recruiting
NCT06879041AstraZenecaAZD2287

A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer

Start: Mar 2025Est. completion: Apr 202995 patients
Phase 1Recruiting
NCT06492122Full-Life Technologies[225Ac]Ac-FL-020

Study With [225Ac]Ac-FL-020 in mCRPC Participants

Start: Aug 2024Est. completion: Dec 202650 patients
Phase 1Recruiting
NCT06318273AbbVieABBV-969

A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer

Start: Mar 2024Est. completion: May 2027140 patients
Phase 1Recruiting
NCT06244485Daiichi SankyoValemetostat

A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors

Start: Feb 2024Est. completion: Nov 2028210 patients
Phase 1Recruiting
NCT05725070ARTBIO212Pb-NG001

Phase 0/1 Study of 212Pb-NG001 in mCRPC

Start: Mar 2023Est. completion: Jul 2023
Phase 1Completed
NCT04879589Antares TherapeuticsAbiraterone Acetate

Phase 1 Study of ATRS-2002 in Healthy Male Adults

Start: Sep 2022Est. completion: Apr 2023
Phase 1Withdrawn
NCT04853498Chia Tai TianQing Pharmaceutical GroupTQB3720

A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets

Start: Jun 2021Est. completion: May 2023
Phase 1Unknown
NCT04740034AmgenAMG 340

A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma

Start: Apr 2021Est. completion: Jun 202442 patients
Phase 1Terminated
NCT04575766Novo NordiskFT-7051

A Study of FT-7051 in Men With MCRPC

Start: Dec 2020Est. completion: Nov 202225 patients
Phase 1Terminated
NCT03835533City TherapeuticsNKTR-214

Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations

Start: Jun 2019Est. completion: Oct 202243 patients
Phase 1Completed
NCT02744287RegeneronBPX-601

Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors

Start: Nov 2016Est. completion: Mar 202352 patients
Phase 1Terminated
NCT01594918SanofiCabazitaxel

Phase I Cabazitaxel, Mitoxantrone, and Prednisone Metastatic Castration-Resistant Prostate Cancer

Start: Jun 2012Est. completion: Jun 201725 patients
Phase 1Completed
NCT01606982AstellasMDV3100

Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

N/AApproved For Marketing
NCT06514521NovartisLutetium vipivotide tetraxetan

Post Marketing Study on Pluvicto in Korea

Start: Apr 2025Est. completion: May 2028278 patients
N/ARecruiting
NCT06517719NovartisLutetium vipivotide tetraxetan

Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

Start: Sep 2024Est. completion: Feb 2028500 patients
N/ARecruiting
NCT04000776Merck & Co.FDG Positron emission tomography

3TMPO (Triple-Tracer Strategy Against Metastatic Prostate Cancer

Start: Dec 2019Est. completion: Jun 2023
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
9 actively recruiting trials targeting 2,325 patients
26 companies competing in this space

Related Indications

Breast Cancer(530)Non-small Cell Lung Cancer(373)Prostate Cancer(371)Multiple Myeloma(244)Advanced Solid Tumors(221)Acute Myeloid Leukemia(204)Cancer(187)Neoplasms(173)Colorectal Cancer(166)Advanced Solid Tumor(165)