RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Starting soon · Phase 2

Conditions studied: Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

In brief

This is a prospective, interventional, non-randomized, phase 2 study to assess oncologic outcomes of metastatic hormone-sensitive prostate cancer (mCSPC) patients who receive a risk-adapted treatment approach followed by treatment de-escalation at the Medstar Health network. A pragmatic design will be implemented in order to make the study available to patients at greatest needs from minority populations in the community. Additional assessments include quality-of-life (QoL) and sexual function changes as well as correlative studies. A maximum of 108 patients will be enrolled in this study. The investigators hypothesize that with a risk-adapted treatment approach followed by treatment de-escalation, more than 50% of patients will have radiographic progression-free survival (rPFS) at 36 months. Additionally, the investigators hypothesize that the risk-stratified de-escalation approach will result in fewer treatment-related adverse events and better QoL, compared to historical controls.

Key facts

Study ID

NCT07645326

Run by

Georgetown University

People needed

108

Starts

2026-08-01

Expected to finish

2032-08-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patients who can give informed consent and are willing to comply with follow-up visits and treatment plans.

You may not qualify if…

• 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.
• Patients who have received prior treatment with any of the following:
• Chemotherapy other than docetaxel for prostate cancer any time prior to enrollment;
• Radiopharmaceuticals for prostate cancer any time prior to enrollment.
• Patients who have received treatment with radiotherapy (EBRT, brachytherapy, or radiopharmaceuticals) within 2 weeks before prior to the start of study treatment.
• Patients with prior treatment with an ARPI for non-metastatic disease within 6 months of diagnosis of metastatic disease are not eligible.
• a. Note: Patients who were diagnosed with metastatic disease or more than 6 months after treatment with an ARPI non-metastatic disease are eligible.
• 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).
• Patients with an inability to swallow oral medications in the opinion of the clinical investigator.
• Patients with leptomeningeal disease.

Where it is running

• Georgetown University Medical Center- Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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