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NCT07645326 · ClinicalTrials.gov registry record · Phase 2
RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
A Phase 2 study, sponsored by Georgetown University.
- Not yet
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
NCT07645326: Clinical Trial Phase 2 study, sponsored by Georgetown University.
NCT07645326 is a Phase 2 study that has not yet begun recruiting, run by Georgetown University. The registered enrollment target is 108 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07645326, a Phase 2 study, has not yet begun recruiting, sponsored by Georgetown University.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
Study Summary
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.
Primary Outcome
rPFS is defined as the time from the first dose of systemic therapy for mCSPC to the first documented radiological progression in soft tissue or bone, based on CT, MRI, or NM bone scan, using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for soft-tissue metastases and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases, or death from any cause.
Interventions
- DRUG Docetaxel
- DRUG Androgen Deprivation Therapy (ADT)
- DRUG Androgen Receptor Pathway Inhibitor (ARPI)
- RADIATION Prostate Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2026-08 |
| Est. Completion | 2032-08 |
| Phase | Phase 2 |
What is known before NCT07645326 opens enrollment
NCT07645326 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.
NCT07645326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07645326 about?
NCT07645326 is a clinical study titled "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 ...
What is the current status of trial NCT07645326?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2026-08. Estimated completion is 2032-08.
What interventions are being tested in trial NCT07645326?
The interventions under investigation include: Docetaxel (DRUG), Androgen Deprivation Therapy (ADT) (DRUG), Androgen Receptor Pathway Inhibitor (ARPI) (DRUG), Prostate Radiation (RADIATION).
Who is sponsoring clinical trial NCT07645326?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07645326's enrollment target sits among peer trials
108 640th of 2000 higher than 1,355 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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