Protocol: A032101
Please Note: Below is partial eligibility, for full eligibility requirements, please contact Genesys Hurley Cancer Institute, Research Department at (810)762-8181, (810)762-8079 and/or (810)762-8038. Thank you!
Eligibility:
- Histologic or clinical diagnosis of metastatic prostate cancer. Must have had evidence of metastatic disease by bone scan, or nodal or visceral lesions on CT or MRI prior to starting on intense ADT. Radiographic evidence of disease is not required at the time of enrollment. No metastases to liver or to brain ,as these represent aggressive variant disease biology for which intermittent treatment may not be favored.
- Must currently be receiving intense ADT for metastatic hormone sensitiveprostate cancer (mHSPC). o Testosterone suppression (TS) with luteinizing hormone releasing hormone (LHRH)-agonist or LHRH-antagonist AND
o An approved secondary androgen receptor pathway inhibitor (ARPI) abiraterone, enzalutamide, or apalutamide (or darolutamide if approved for this indication). - Must have remained on testosterone suppression for metastatic disease continuously (without treatment breaks) for 540-750 days (approximately 18 to 24 months) from time of first dose of LHRH agonist or antagonist by time of
registration. A period of anti-androgen treatment prior to LHRH agonist or antagonist initiation is not included in the 540 – 750 days (approximately 18 to 24 months). - Must have received treatment with ARPI for at least 360 days in total by time of A032101 registration. Treatment breaks from ARPI of up to 28 days are permitted (for example peri-procedural or for management of a temporary adverse event) as long as PSA did not rise while holding therapy.
- Prior TS in the context of neoadjuvant/concurrent/adjuvant treatment with local therapy is permitted. Prior course(s) of intermittent TS for biochemical-only recurrence is permitted. However, if the patient previously received TS, metastatic
progression for which intense ADT was initiated must have occurred during an offtreatment interval and with testosterone ≥ 150 ng/dL. - Prior local therapy for prostate cancer (either before or after diagnosis of metastatic disease) is permitted. Prior treatment with docetaxel chemotherapy for up to 6 cycles is permitted. Prior radiation therapy to metastatic sites (either for
symptom palliation or for ablation of oligometastatic disease) is permitted. - No history of surgical castration.
- No history of ARPI use prior to diagnosis of mHSPC for which the patient is currently receiving intense ADT (such as in the neoadjuvant setting with prior local therapy).
- No current or prior treatment with experimental agents for metastatic hormonesensitive prostate cancer.
10. Age ≥ 18 years
11. ECOG Performance Status 0-2
12. No patients with a “currently active” second malignancy. Patients with non-melanomatous skin cancer, superficial bladder cancer, cancer not needing active therapy for at least 2 years, cancer for which the treating investigator deems the subject to be in remission, or any prior malignancy that was treated with curative intent (no evidence of disease for at least 3 years) are also permitted to enroll. Patients are not considered to have a “currently active” malignancy if they have
completed therapy and are free of disease for ≥ 3 years.