Disease

Prostate carcinoma

Late-stage therapeutic development

Also known as carcinoma of prostate, carcinoma of prostate gland, carcinoma of the prostate, prostate gland carcinoma+3 more

carcinoma of prostate, carcinoma of prostate gland, carcinoma of the prostate, prostate gland carcinoma, cancer of prostate, cancer of the prostate, prostate cancer, NOS.

Clinical trials

Associated genes

Related proteins

Current focus

Androgen biologyProstate-specific biologyTherapeutic developmentDisease mechanisms & pathology

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this disease.

A Single Arm, Multicenter, Prospective, Open Label, Longitudinal Phase 3 Study of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) Combined With Magnetic Resonance Imaging (MRI) Compared to Standard of Care (SOC) for the Detection of Prostate Cancer (PCa).

Clinical trial2026-10-20Status changed to Active, not recruiting · ClinicalTrials.gov

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate

Key developments

6 clinical trials expected to report results, the earliest in Q2 2029.

Upcoming Milestones

Major developments

Upcoming trial readoutHigh impact

Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)

Results expected Q3 20342026-10-02

Upcoming trial readoutHigh impact

Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

Results expected Q4 20312026-09-02

Clinical Milestones13View all 13

Results posted 3

Results expected 5

2026-10-02Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)Results expected Q3 2034
2026-09-02Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)Results expected Q4 2031
2026-08-19Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)Results expected Q4 2032
2026-07-31A Randomized Phase III Trial With a Factorial Design Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse, From the Prostate Cancer Consortium in Europe (PEACE)Results expected Q4 2033
2026-02-24Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate (AA) Versus Relugolix Plus AA for Advanced Prostate Cancer: The REVELUTION-2 TrialResults expected Q3 2029

Other updates 4

+5 more in the activity timeline below

Activity timeline13

2028-07-01ClinicalPhase II Study to Evaluate the Performance of PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Clinically Significant Prostate Cancer in Men Presenting Following a Positive Screen for Prostate CancerWithdrawn
2028-06-01ClinicalSingle-Arm, Open-Label, Phase II Study of Pembrolizumab Plus Androgen Deprivation Therapy (ADT) in Combination With Radiotherapy (RT) for High Risk Localized Prostate CancerWithdrawn
2026-10-02ClinicalRadioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)Results expected Q3 2034
2026-09-02ClinicalDocetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)Results expected Q4 2031
2026-08-19ClinicalPhase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)Results expected Q4 2032
2026-07-31ClinicalA Randomized Phase III Trial With a Factorial Design Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse, From the Prostate Cancer Consortium in Europe (PEACE)Results expected Q4 2033
2026-07-02ClinicalPhase 2 Study of CJNJ-67652000 (Niraparib/Abiraterone Acetate Fixed-Dose Combination) and Prednisone for Metastatic Castration-Resistant Prostate Cancer Associated With SPOP Mutation With or Without Homologous Recombination DeficiencyTerminated
2026-06-25ClinicalAndrogen Receptor Modulation Phase II, Randomized Study of MK-2206 - Bicalutamide Combination in Patients With Rising PSA at High-Risk of Progression After Primary TherapyResults posted
2026-06-25ClinicalClinical Study of Bioactivity of Low Dose Apalutamide in Prostate Cancer Patients Scheduled for ProstatectomyResults posted
2026-06-09ClinicalPhase II Trial of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf (HP) Plus Enzalutamide for the Treatment of Selected Patients With Metastatic Castration-Resistant Prostate Cancer (TraPPer)Results posted

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies

Olaparibapproved

Original application approval — Ovarian cancer Lynparza is indicated as monotherapy for the: maintenance treatment of ad… (2014)

Docetaxelapproved

Generic approval — Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indi… (2012)

Clinical trials

12 sponsors · 2 new · 2 completed in the last 12 months (net +0)

The current development programme across all trial phases.

Clinical programme

All trials

Active

Late-stage

Completed

Late-stage studies

A Randomized Phase III Trial With a Factorial Design Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse, From the Prostate Cancer Consortium in Europe (PEACE)

Phase 3 · Recruiting · UNICANCER

Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

Phase 3 · Recruiting · Alliance for Clinical Trials in Oncology

Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)

Phase 3 · Recruiting · Alliance for Clinical Trials in Oncology

A Phase III Study of Cabazitaxel With or Without Carboplatin in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC), Stratified by Aggressive Variant Signature

Phase 3 · Recruiting · SWOG Cancer Research Network

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Phase 3 · Recruiting · ECOG-ACRIN Cancer Research Group

Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate (AA) Versus Relugolix Plus AA for Advanced Prostate Cancer: The REVELUTION-2 Trial

Phase 3 · Recruiting · Emory University

Recruiting

Phase 3 · Recruiting · UNICANCER

Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

Phase 3 · Recruiting · Alliance for Clinical Trials in Oncology

Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)

Phase 3 · Recruiting · Alliance for Clinical Trials in Oncology

A Phase III Study of Cabazitaxel With or Without Carboplatin in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC), Stratified by Aggressive Variant Signature

Phase 3 · Recruiting · SWOG Cancer Research Network

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Phase 3 · Recruiting · ECOG-ACRIN Cancer Research Group

Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate (AA) Versus Relugolix Plus AA for Advanced Prostate Cancer: The REVELUTION-2 Trial

Phase 3 · Recruiting · Emory University

Recently completed

Phase II Trial of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf (HP) Plus Enzalutamide for the Treatment of Selected Patients With Metastatic Castration-Resistant Prostate Cancer (TraPPer)

Phase 2 · Completed · Mayo Clinic

Clinical Study of Bioactivity of Low Dose Apalutamide in Prostate Cancer Patients Scheduled for Prostatectomy

Phase 2 · Completed · National Cancer Institute (NCI)

A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oxybutynin Versus Placebo for the Treatment of Hot Flashes in Men Receiving Androgen Deprivation Therapy

Phase 2 · Completed · Alliance for Clinical Trials in Oncology

68Ga-PSMA-11 PET/CT for Screening Prior to 177Lu-PSMA-617 Therapy

Phase 3 · Completed · Mayo Clinic

[18F]Fluciclovine Companion Imaging Study to Radium-223 and Radiotherapy in Hormone-Naive Men With Oligometastatic Prostate Cancer to Bone (RROPE) Study

Phase 2 · Completed · University of Utah

Androgen Receptor Modulation Phase II, Randomized Study of MK-2206 - Bicalutamide Combination in Patients With Rising PSA at High-Risk of Progression After Primary Therapy

Phase 2 · Completed · National Cancer Institute (NCI)

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

Product approvals and authorisations

2014emaOriginal application approval — Olaparib· Ovarian cancer Lynparza is indicated as monotherapy for the: maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. Lynparza in combination with bevacizumab is indicated for the: maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability (see section 5.1). Breast cancer Lynparza is indicated as: monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1). monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. Adenocarcinoma of the pancreas Lynparza is indicated as: monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. Prostate cancer Lynparza is indicated as: monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated (see section 5.1). Endometrial cancer Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel. source ↗

2012emaGeneric approval — Docetaxel· Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Kabi monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer. Docetaxel Kabi in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer. Gastric adenocarcinoma Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. source ↗

2012emaGeneric approval — Docetaxel· Breast cancer Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Accord in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. source ↗

1995emaOriginal application approval — Docetaxel· Breast cancer Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Associated genes

12 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

AR0.74 SRD5A20.62 TMPRSS20.60 FDPS0.59 KLK30.59 GNRHR0.59 TCF7L20.58 ZFHX30.57 CDKN1B0.56 ANO70.56 KLF60.56 SRD5A10.56

Disease biology

12 matches

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

Androgen receptorvia AR0.74 3-oxo-5-alpha-steroid 4-dehydrogenase 2via SRD5A20.62 Farnesyl pyrophosphate synthasevia FDPS0.59 Prostate-specific antigenvia KLK30.59 Gonadotropin-releasing hormone receptorvia GNRHR0.59 3-oxo-5-alpha-steroid 4-dehydrogenase 1via SRD5A10.56 Polyprenal reductasevia SRD5A30.55 Mitogen-activated protein kinase kinase kinase 1via MAP3K10.51 G1/S-specific cyclin-D1via CCND10.50 Apoptosis regulator Bcl-2via BCL20.50 Krueppel-like factor 4via KLF40.48 Matrilysinvia MMP70.48

Reference

Authoritative identity, definition & identifiers.

Synonyms

carcinoma of prostate, carcinoma of prostate gland, carcinoma of the prostate, prostate gland carcinoma, cancer of prostate, cancer of the prostate, prostate cancer, NOS

References & data sources

Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
Related entities are derived from literature co-mention (studied together) — associative, not causal.