drugset / Trial / NCT03516812

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

NCT03516812

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-08-29
Primary completion
2021-03-05
Completion
2024-04-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaparib Small molecule Oral
Subject Testosterone Cypionate Small molecule Intramuscular
Subject Testosterone Enanthate Small molecule Intramuscular