1. Adult patients with metastatic castrate sensitive prostate cancer that are eligible for standard of care (SOC) per treating physician.
a. Low risk SOC: ADT + ARPI + radiation to the prostate i. For patients with low-risk disease (defined in Section 8.1), prior treatment with ADT or ARPI for up to 8 weeks for mCSPC is permitted; however, prior treatment with docetaxel is not allowed.
b. High risk SOC: ADT + ARPI +/- docetaxel i. For patients with high-risk disease (defined in Section 8.1), prior treatment with ADT, ARPI, or docetaxel for up to 8 weeks for mCSPC is permitted.
2. Patients who can give informed consent and are willing to comply with follow-up visits and treatment plans.
You may not be if
1. Patients for whom, in the opinion of the investigator, participation in the study, use of the drugs outlined in the study, or use of the risk-adapted treatment de-escalation strategy is not appropriate or safe.
2. Patients who have received prior treatment with any of the following:
1. Chemotherapy other than docetaxel for prostate cancer any time prior to enrollment;
2. Radiopharmaceuticals for prostate cancer any time prior to enrollment.
3. Patients who have received treatment with radiotherapy (EBRT, brachytherapy, or radiopharmaceuticals) within 2 weeks before prior to the start of study treatment.
a. Note: Patients who were diagnosed with metastatic disease or more than 6 months after treatment with an ARPI non-metastatic disease are eligible.
5. Patients who had previous (within 28 days before the start of study drug or 4 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).
6. Patients with an inability to swallow oral medications in the opinion of the clinical investigator.
7. Patients with leptomeningeal disease.
Clareo Health | RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
