Clinical Trial

Testing Experimental Treatment for Prostate Cancer

Study Description

BRcA Deficient Prostate Cancer Treated With Carboplatin or Docetaxel

This is an unblinded, randomized clinical study comparing the efficacy of DNA damaging chemotherapy using carboplatin, to standard of care chemotherapy for patients who have metastatic castrate resistant prostate cancer. This trial will use docetaxel or carboplatin as initial chemotherapy with crossover to the alternate or second-line drug after first progression for patients with tumors containing BRCA1, BRCA2 or PALB2 inactivating DNA mutations. Participants are randomized (1:1) and receive either carboplatin (AUC 5) first or docetaxel (75 mg/m2) every 21 days until intolerance, complete response, or progression by Prostate Cancer Working Group 3 (PCWG3) criteria or 10 cycles (whichever is first). Participants then crossover from the first-line therapy to the second-line therapy with the opposite study medication and receive treatment to intolerance or progression or 10 cycles (whichever is first). Enrolled participants will be allowed to crossover to second line therapy if they continue to meet initial eligibility criteria, and at least three weeks have elapsed since last administration of either carboplatin or docetaxel. Throughout the study, safety and tolerability will be assessed. Progression will be evaluated with bone scan, CT of the abdomen/pelvis, or MRI and PSA as per PCWG3 criteria.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Carboplatin

Chemotherapy FDA approved drug used to treat: ovarian, lung, head and neck cancers. It is sometimes used in combination with other medications or off-label use to treat other metastatic cancers.

Drug - Docetaxel

Chemotherapy FDA approved drug used to treat many types of cancer including: breast, prostate, stomach, head and neck and non-small cell lung cancer.

Additional Information

Official Study Title

Multicenter Phase II Study of First-line Carboplatin Followed by Docetaxel Versus First-line Docetaxel Followed by Carboplatin for Treatment of Castration Resistant Prostate Cancer

Clinical Trial ID

NCT04038502

ParticipAid ID

eEREYa