This study is currently not recruiting participants.

NCI9012; A Randomized Gene Fusion Stratified Phase 2 Trial Of Abiraterone With Or Without ABT 888 For Patients With Metastatic Castration-Resistant Prostate Cancer

Investigating the Effectiveness of Hormone and PARP-1 Targeted Therapy in Metastatic Prostate Cancer

Not Recruiting
18 years - 100 years
Male
Phase N/A

Brief description of study.

This randomized phase II trial studies abiraterone acetate and prednisone together with veliparib to see how well it works compared to abiraterone acetate and prednisone alone in treating patients with metastatic hormone-resistant prostate cancer.

Detailed description of study

The purpose of this study is to evaluate the role of v-ets erythroblastosis virus E26 oncogene (ETS) gene fusion as a predictive biomarker for response to hormone therapy (abiraterone [abiraterone acetate]) alone or hormone therapy plus poly adenosine diphosphate-ribose polymerase 1 (PARP-1) targeted therapy (ABT-888 [veliparib]) in patients with metastatic castration resistant prostate cancer, and to evaluate whether the addition of PARP-1 targeted therapy is superior to hormone therapy alone based on ETS gene fusion status.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Prostate Cancer
  • Age: 18 years - 100 years
  • Gender: Male

This study investigates the effectiveness of combining an investigational medication with hormone therapy in treating metastatic hormone-resistant prostate cancer. The purpose is to evaluate if adding a PARP-1 targeted therapy, which is a type of treatment that blocks certain proteins in cancer cells, is more effective than hormone therapy alone. The study will also look at the role of a specific gene fusion, called ETS, to see if it can predict how well patients respond to these treatments.

Participants will be randomly assigned to one of two study arms. One arm will receive hormone therapy together with the investigational medication, while the other arm will receive hormone therapy alone. The study will involve regular assessments to monitor the participants' health and the effectiveness of the treatment.

  • Who can participate: The study is for patients aged 18 and older with metastatic hormone-resistant prostate cancer. Participants must have the ETS gene fusion to be eligible.
  • Study details: Participants will be randomly assigned to receive either hormone therapy with an investigational medication or hormone therapy alone. The investigational medication is a PARP-1 targeted therapy that aims to block certain proteins in cancer cells.
Updated on 19 Feb 2024. Study ID: 1212010175

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