Protocol: Alliance – A031902
Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038. Thank you!
- Histologic/cytologic documentation of prostate adenocarcinoma.
- Radiographic progression per RECIST 1.1 criteria for soft tissue lesions.
- Measurable or non-measurable metastatic disease.
- No prior therapy for metastatic castration-resistant prostate cancer, defined as a treatment given for prostate cancer with radiographically-detectable metastasis and a serum testosterone level less than 50 ng/dl (1.73 nmol/L).
- ≥2 weeks or 5 half-lives (whichever is longer) since prior therapy with flutamide, dutasteride, bicalutamide, niltamide, finasteride, aminoglutethimide, estrogens, cytoproterone, chemotherapy, abiraterone, apalutamide, or darolutamide.
- ≥4 weeks or 5 half-lives (whichever is longer) since any prior investigational therapy.
- ≥4 weeks since a major surgery or radiation.
- No prior therapy with enzalutamide, rucaparib or any other PARP inhibitor, or platinum chemotherapy.
- Prior docetaxel and/or novel antiandrogen use is allowed only if given in the hormone-sensitive disease setting.
- Patient must have discontinued all previous treatments for cancer (except ADT and bone anti-responsive therapies such as denosumab or zoledronic acid) and must have recovered from all acute side effects of prior therapy or surgical procedures to ≤ Grade 1 or baseline prior to randomization, with the exception of fatigue, alopecia or peripheral neuropathy.
- At least 18 years of age.
- ECOG Performance Status 0-2
- No prior malignancy for which the last treatment was given within the past 2 years prior to pre-registration on A031902, or any active concurrent malignancy with the exception of non-melanomatous localized skin cancers (such as squamous or basal cell carcinoma of the skin).