January 24, 2022 Prostate Metastatic

Protocol: Alliance – A031902

Please Note: Below is a partial list of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038 to discuss the full eligibility requirements.

Eligibility:

SCHEMA A031902

  1. Histologic/cytologic documentation of prostate adenocarcinoma.
  2. Radiographic progression per RECIST 1.1 criteria for soft tissue lesions.
  3. Measurable or non-measurable metastatic disease.
  4. 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).
  5. ≥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.
  6. ≥4 weeks or 5 half-lives (whichever is longer) since any prior investigational therapy.
  7. ≥4 weeks since a major surgery or radiation.
  8. No prior therapy with enzalutamide, rucaparib or any other PARP inhibitor, or platinum chemotherapy.
  9. Prior docetaxel and/or novel antiandrogen use is allowed only if given in the hormone-sensitive disease setting.
  10. 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.
  11. At least 18 years of age.
  12. ECOG Performance Status 0-2
  13. 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).

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