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

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.

NCT Number	NCT07645326
Lead Sponsor	Georgetown University Collaborators: Lantheus Medical Imaging
Conditions	Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Enrollment	108 participants
Start Date	2026-08
Primary Completion	2032-08 (estimated)
Study Completion	2032-08 (estimated)
Updated on ClinicalTrials.gov	2026-06-17