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

Study acronym: RISK-ADAPT
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Aug 2026 to Dec 2026 Eligibility criteria expanded, about 11 words · Secondary endpoints: details revised at 6 of 12 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 6 of 12 entries
  2. Secondary endpoints revised (12)v2 See this version in full on ClinicalTrials.gov ↗
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07645326
Lead Sponsor Georgetown University
Collaborators: Lantheus Medical Imaging
Conditions Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov