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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 is a Phase 2 study that has not yet begun recruiting, run by Georgetown University. The registered enrollment target is 108 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07645326
The ClinicalTrials.gov registry entry for NCT07645326 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.
NCT07645326 reports 0 study locations.
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.
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