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Testosterone and Olaparib in Treating Patients With Castration-Resistant Prostate Cancer

NCT03516812 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-09-29

Study results available
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Summary

This phase II trial studies how well testosterone (enanthate or cypionate) and olaparib work in treating patients with prostate cancer that has progressed despite hormonal therapy. Hormonal therapy, such as leuprolide, may lessen the amount of male sex hormones made by the body. In patients that have developed progressive cancer in spite of standard hormonal treatment (i.e. castration-resistant prostate cancer), administering testosterone may result in regression of tumors by causing DNA damage in cancer cells that have adapted to low testosterone conditions. Olaparib may stop the growth of tumor cells by blocking some of the enzymes involved in repairing DNA damage. Therefore, giving testosterone and olaparib together may work better in treating castration-resistant prostate cancer by generating DNA damage that the cancer cell is unable to repair.

Conditions

  • Castration-Resistant Prostate Carcinoma
  • Prostate Adenocarcinoma

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Olaparib

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Survey Administration

Ancillary studies

DRUG

Testosterone Enanthate

Given IM

DRUG

Testosterone Cypionate

Given IM

Sponsors & Collaborators

Principal Investigators

  • Michael T. Schweizer · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2021-03-05
Completion
2024-04-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03516812 on ClinicalTrials.gov