Who is sponsoring NCT03248570?

NCT03248570 is sponsored by University of California, San Francisco.

What drugs are being tested in NCT03248570?

Interventions in NCT03248570: Pembrolizumab, Chemotherapy.

What condition does NCT03248570 study?

NCT03248570 studies Castration Resistant Prostatic Cancer, Metastatic Prostate Cancer.

Is NCT03248570 still recruiting?

NCT03248570 is currently completed. Last updated 20 November 2024.

Are results published for NCT03248570?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-11-20 · How we verify

NCT03248570

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pembrolizumab in Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without DNA Damage Repair Defects

Completed Phase 2 Results posted Last updated 20 November 2024

What this trial tests

Phase 2 trial testing Pembrolizumab in Castration Resistant Prostatic Cancer in 26 participants. Completed in 28 September 2023.

Timeline

20 February 2018

Primary endpoint
28 September 2023

28 September 2023

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	20 February 2018
Primary completion	28 September 2023
Estimated completion	28 September 2023
Sites	1 location across United States

Drugs / interventions tested

Pembrolizumab (pembrolizumab) — full drug profile →
Chemotherapy (chemotherapy) — full drug profile →

Conditions studied

Castration Resistant Prostatic Cancer — all drugs for Castration Resistant Prostatic Cancer →
Metastatic Prostate Cancer — all drugs for Metastatic Prostate Cancer →

Sponsor

University of California, San Francisco

Who can join

18 and older, male only, with Castration Resistant Prostatic Cancer or Metastatic Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Radiographic Progression-Free Survival Rate (rPFS) at 6 Months Primary · Up to 6 months

The rPFS rate is defined as the proportion of participants still alive at 6 months starting from the first day of study treatment with pembrolizumab. Participants will be censored on the date of documented tumor progression according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines or death due to any cause at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. The 6-month rPFS rate and the 95% confidence interval will be reported by study group.

Group	Value	95% CI
DNA Damage Repair Proficient Group	0.513	0.296 – 0.888
DNA Damage Repair Defective Group	0.63	0.402 – 1.00

Median Overall Radiographic Progression-free Survival (rPFS) Primary · Up to 24 months

The median overall radiographic progression free survival (rPFS) is defined as the time from the first day of study treatment with pembrolizumab to the date of documented radiographic tumor progression according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines or death due to any cause, whichever occurs first. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. The median time in months and the 95% confidence interval will be reported by study group.

Group	Value	95% CI
DNA Damage Repair Proficient Group	10.43	4.28 – NA
DNA Damage Repair Defective Group	7.89	4.61 – NA

Immune-related Progression-free Survival Rate (irPFS) at 20 Weeks Secondary · Up to 20 weeks

The immune-related Progression Free Survival rate (irPFS) is defined as the proportion of participants still alive at 20 weeks from the first day of study treatment with pembrolizumab. Participants will be censored on the date of documented tumor progression according to the immune-related response criteria (irRC) for immune-related progression or death due to any cause at 20 weeks. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. The 20-week irPFS rate and the 95% confidence interval will be reported by study group.

Group	Value	95% CI
DNA Damage Repair Proficient Group	0.513	0.296 – 0.888
DNA Damage Repair Defective Group	0.648	0.421 – 0.998

Immune-related Progression-free Survival Rate (irPFS) at 28 Weeks Secondary · Up to 28 weeks

The immune-related Progression Free Survival rate (irPFS) is defined as the proportion of participants still alive at 28 weeks from the first day of study treatment with pembrolizumab. Participants will be censored on the date of documented tumor progression according to the immune-related response criteria (irRC) for immune-related progression or death due to any cause at 28 weeks. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. The 28-week irPFS rate and the 95% confidence interval will be reported by study group.

Group	Value	95% CI
DNA Damage Repair Proficient Group	0.513	0.296 – 0.888
DNA Damage Repair Defective Group	0.648	0.421 – 0.998

Overall Progression-Free Survival Rate (PFS) at 20 Weeks Secondary · Up to 20 weeks

The overall progression free survival rate (PFS) is defined as the proportion of participants still alive from the first day of study treatment with pembrolizumab at 20 weeks. Participants will be censored on the date of documented tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines or death due to any cause at 20 weeks. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. The 20-week overall PFS rate and the 95% confidence interval will be reported by study group.

Group	Value	95% CI
DNA Damage Repair Proficient Group	0.462	0.257 – 0.83
DNA Damage Repair Defective Group	0.556	0.328 – 0.941

Overall Progression-Free Survival Rate (PFS) at 28 Weeks Secondary · Up to 28 weeks

The overall progression free survival rate (PFS) is defined as the proportion of participants still alive from the first day of study treatment with pembrolizumab at 28 weeks. Participants will be censored on the date of documented tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines or death due to any cause at 28 weeks. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. The 28-week overall PFS rate and the 95% confidence interval will be reported by study group.

Group	Value	95% CI
DNA Damage Repair Proficient Group	0.462	0.257 – 0.83
DNA Damage Repair Defective Group	0.556	0.328 – 0.941

Percentage of Participants Achieving Any Prostate Specific Antigen (PSA) Response Secondary · Up to 24 months

The percentage of participants with a demonstrated PSA response will be reported for each group along with the 95% confidence interval.

Group	Value	95% CI
DNA Damage Repair Proficient Group	57.1	28.9 – 82.3
DNA Damage Repair Defective Group	58.3	27.7 – 84.8

Percentage of Participants Achieving Any PSA Decline ≥ 50% Secondary · Up to 24 months

The percentage of participants with a demonstrated PSA decline \>= 50% will be reported for each group along with the 95% confidence interval.

Group	Value	95% CI
DNA Damage Repair Proficient Group	21.4	4.7 – 50.8
DNA Damage Repair Defective Group	41.7	15.2 – 72.3

Number of Participants Reporting Any Pembrolizumab Treatment-related Adverse Events Secondary · Up to 24 months

All participants will be evaluated for toxicity from the time of the first treatment with pembrolizumab. The number of participants with adverse events defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and categorized as having a possible, probable, or definite attribution to the administration of pembrolizumab from the start of treatment until 30 days after the end of treatment will be reported for each group.

Group	Value	95% CI
DNA Damage Repair Proficient Group	11
DNA Damage Repair Defective Group	11

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DNA Damage Repair Proficient Group

Serious: 1/14 (7%)

Deaths: 8/14

DNA Damage Repair Defective Group

Serious: 7/12 (58%)

Deaths: 8/12

Serious adverse events (11 terms)

Reaction	System	DNA Damage Repair Proficie…	DNA Damage Repair Defectiv…
Sepsis	Infections and infestations	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	—	—
Renal and urinary disorders - Other	Renal and urinary disorders	—	—
Skin infection	Skin and subcutaneous tissue disorders	—	—
Urinary tract pain	Renal and urinary disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—
Pathologic femur fracture	Musculoskeletal and connective tissue disorders	—	—
Soft tissue infection	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—

Other adverse events (63 terms — click to expand)

Reaction	System	DNA Damage Repair Proficie…	DNA Damage Repair Defectiv…
Fatigue	General disorders	—	—
General disorders and administration site conditions - Other, specify	General disorders	—	—
Anemia	Blood and lymphatic system disorders	—	—
Weight loss	Investigations	—	—
Nausea	Gastrointestinal disorders	—	—
Pain	General disorders	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—
Skin and subcutaneous tissue disorders - Other, specify	Skin and subcutaneous tissue disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Anorexia	Metabolism and nutrition disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	—	—
Edema limbs	General disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Fall	Injury, poisoning and procedural complications	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—
Headache	Nervous system disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	—	—
Hearing impaired	Ear and labyrinth disorders	—	—
Hypothyroidism	Endocrine disorders	—	—
Endocrine disorders - Other, specify	Endocrine disorders	—	—
Eye disorders - Other, specify	Eye disorders	—	—
Facial Pain	General disorders	—	—
Infections and infestations - Other, specify	Infections and infestations	—	—
Bruising	Injury, poisoning and procedural complications	—	—
Alkaline phosphatase increase	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Creatinine Increased	Investigations	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—

Most-reported serious reactions: Sepsis, Hypoxia, Thrombotic thrombocytopenic purpura, Renal and urinary disorders - Other, Skin infection, Urinary tract pain, Atrial fibrillation, Back Pain.

Data from ClinicalTrials.gov NCT03248570 adverse events section.

Sponsor's own description

This is a multicenter phase 2 open label study of pembrolizumab in patients with metastatic castrate resistant prostate cancer (mCRPC) with or without DNA damage repair defects.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

How to turn up the heat on the cold immune microenvironment of metastatic prostate cancer.
Stultz J, Fong L. · · 2021 · cited 173× · PMID 33820953 · DOI 10.1038/s41391-021-00340-5
Evolution of myeloid-mediated immunotherapy resistance in prostate cancer.
Lyu A, Fan Z, Clark M, Lea A, et al · · 2025 · cited 107× · PMID 39633050 · DOI 10.1038/s41586-024-08290-3
Is There a Role for Immunotherapy in Prostate Cancer?
Rizzo A, Mollica V, Cimadamore A, Santoni M, et al · · 2020 · cited 68× · PMID 32911806 · DOI 10.3390/cells9092051
Immune Checkpoint Inhibitors in Advanced Prostate Cancer: Current Data and Future Perspectives.
Rebuzzi SE, Rescigno P, Catalano F, Mollica V, et al · · 2022 · cited 40× · PMID 35267553 · DOI 10.3390/cancers14051245
Current Status and Future Perspectives of Checkpoint Inhibitor Immunotherapy for Prostate Cancer: A Comprehensive Review.
Kim TJ, Koo KC. · · 2020 · cited 38× · PMID 32751945 · DOI 10.3390/ijms21155484
Sialylated glycoproteins suppress immune cell killing by binding to Siglec-7 and Siglec-9 in prostate cancer.
Wen RM, Stark JC, Marti GEW, Fan Z, et al · · 2024 · cited 34× · PMID 39436703 · DOI 10.1172/jci180282
Molecular Mechanisms of Prostate Cancer Development in the Precision Medicine Era: A Comprehensive Review.
Maekawa S, Takata R, Obara W. · · 2024 · cited 27× · PMID 38339274 · DOI 10.3390/cancers16030523
Immune checkpoint inhibitors in mCRPC - rationales, challenges and perspectives.
Taghizadeh H, Marhold M, Tomasich E, Udovica S, et al · · 2019 · cited 25× · PMID 31646092 · DOI 10.1080/2162402x.2019.1644109

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03248570 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
Last refreshed: 20 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03248570.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing