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NCT04951492

Olaparib for the Treatment of Castration Resistant Prostate Adenocarcinoma

Terminated Phase 2 Results posted Last updated 1 January 2025
What this trial tests

Phase 2 trial testing Olaparib in Castration-Resistant Prostate Carcinoma in 2 participants. Terminated before completion.

Timeline
9 November 2022
Primary endpoint
15 October 2023
15 October 2023

Quick facts

Lead sponsorUniversity of Washington
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment2
Start date9 November 2022
Primary completion15 October 2023
Estimated completion15 October 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

18 and older, male only, with Castration-Resistant Prostate Carcinoma or Prostate Adenocarcinoma. 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.

Lowest On-treatment Prostate Specific Antigen (PSA) Primary · At least 12 weeks of olaparib treatment

The proportion of patients achieving at least a 50% decline in PSA from baseline will be presented.

GroupValue95% CI
Treatment (Olaparib)0
Overall Response Rate (ORR) Secondary · Up to 12.3 weeks

Will be defined as the proportion of participants demonstrating at least a 30% decrease in total tumor size from baseline per Response Evaluation Criteria in Solid Tumors 1.1 criteria at any time point. The percent of patients with ORR and range of values will be provided.

GroupValue95% CI
Treatment (Olaparib)0
Radiographic Progression Free Survival (PFS) Secondary · Up to 12.3 weeks

Radiographic progression will be determined as using RECIST v1.1 and/or PCWG3 criteria. Median PFS will be estimated using the Kaplan-Meier method.

GroupValue95% CI
Treatment (Olaparib)12.311 – 12.3
Prostate Specific Antigen (PSA) Progression Free Survival (PFS) Secondary · Up to 16.6 weeks

PSA progression will be time to for the PSA to increase by at least 2 ng/ml and ≥20% above baseline. PSA PFS will be the time until PSA progression and will be analyzed using kaplan meier method, with the median PSA PFS reported

GroupValue95% CI
Treatment (Olaparib)1212 – 16.6
Overall Survival Secondary · Up to 12.3 weeks

Number of patients who died on study. Note: Plan was to assess time from enrollment to death; however, no deaths have been observed.

GroupValue95% CI
Treatment (Olaparib)0

Adverse events — posted to ClinicalTrials.gov

Time frame: Within 30 days of end of treatment, up to 16.6 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Olaparib)
Serious: 1/2 (50%)
Deaths: 0/2

Serious adverse events (1 terms)

ReactionSystemTreatment (Olaparib)
Pulmonary EmbolismVascular disorders
Other adverse events (15 terms — click to expand)

ReactionSystemTreatment (Olaparib)
NauseaGastrointestinal disorders
FatigueGeneral disorders
AnemiaBlood and lymphatic system disorders
Lymphocyte Count DecreasedInvestigations
AnorexiaMetabolism and nutrition disorders
DiarrheaGastrointestinal disorders
MyalgiaMusculoskeletal and connective tissue disorders
Bone PainMusculoskeletal and connective tissue disorders
Left Forearm TearInjury, poisoning and procedural complications
CoughRespiratory, thoracic and mediastinal disorders
DysgeusiaNervous system disorders
LightheadednessNervous system disorders
White Blood Cell Count DecreasedInvestigations
Neutrophil Count DecreasedInvestigations
Supraventricular TachycardiaCardiac disorders

Most-reported serious reactions: Pulmonary Embolism.

Data from ClinicalTrials.gov NCT04951492 adverse events section.

Sponsor's own description

This phase II trial investigates the effect of olaparib in treating patients with castration resistant prostate adenocarcinoma. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

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

  1. Exploring anti-androgen therapies in hormone dependent prostate cancer and new therapeutic routes for castration resistant prostate cancer.
    Harris AE, Metzler VM, Lothion-Roy J, Varun D, et al · · 2022 · cited 30× · PMID 36263323 · DOI 10.3389/fendo.2022.1006101
  2. The potential of PARP inhibitors in targeted cancer therapy and immunotherapy.
    Hunia J, Gawalski K, Szredzka A, Suskiewicz MJ, et al · · 2022 · cited 25× · PMID 36533080 · DOI 10.3389/fmolb.2022.1073797
  3. Androgen Receptor Signaling Inhibition in Advanced Castration Resistance Prostate Cancer: What Is Expected for the Near Future?
    Pozas J, Álvarez Rodríguez S, Fernández VA, Burgos J, et al · · 2022 · cited 16× · PMID 36551557 · DOI 10.3390/cancers14246071
  4. Management of Advanced Prostate Cancer in the Precision Oncology Era.
    Gillette CM, Yette GA, Cramer SD, Graham LS. · · 2023 · cited 14× · PMID 37174018 · DOI 10.3390/cancers15092552
  5. PARP inhibitors and metastatic castration-resistant prostate cancer: uture directions and pitfalls.
    Franza A, Claps M, Procopio G. · · 2022 · cited 4× · PMID 34763215 · DOI 10.1016/j.tranon.2021.101263
  6. Ferroptosis and prostate cancer: A translational path from molecular mechanisms to precision therapy.
    Huang Y, Ma Y, He J, Song T. · · 2026 · PMID 42233093 · DOI 10.1016/j.gendis.2025.101967

Verify or expand the search:

Other trials of Olaparib

Trials testing the same drug.

Other recruiting trials for Castration-Resistant Prostate Carcinoma

Currently open trials in the same condition.

Other University of Washington trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT04951492.

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