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NCT06150417 · ClinicalTrials.gov registry record · Phase 2
MDRT in Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)
A Phase 2 study of Prostate Cancer and Malignant Neoplasm of Prostate, sponsored by Case Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 2
- Study locations
NCT06150417 is a Phase 2 study of Prostate Cancer and Malignant Neoplasm of Prostate that is actively recruiting participants, run by Case Comprehensive Cancer Center. The registered enrollment target is 200 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06150417, a Phase 2 study of Prostate Cancer and Malignant Neoplasm of Prostate, is actively recruiting participants, sponsored by Case Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to find out if giving radiation therapy (RT) to areas of metastatic prostate cancer at the time a participant is diagnosed will help control disease better than the usual treatment. This treatment is called metastasis-directed radiotherapy (MDRT). The usual treatment for prostate cancer that has spread to other parts of the body is to give lifelong treatment with hormone therapy (also known as androgen deprivation therapy or ADT). Participants may also be given prostate RT even if the disease is metastatic. Participants will receive hormone therapy (the standard treatment for prostate cancer) for 12 months. The hormone therapy agents may be taken by mouth or given as an injection. Participants will also have prostate RT. Up to 50 participants will have surgery to remove the prostate instead of having prostate RT. A portion of the participants will be randomized to receive MDRT to areas where the cancer has spread. For participants who have surgery to remove their prostate, they will be asked to allow tissue samples collected during the surgery to be sent to an outside lab for research tests and extra blood samples drawn for research tests before starting the study, and at the time the cancer becomes worse if applicable. Participation in the study will last approximately 12 months, and will be followed by their doctor for up to five years per standard of care. The main goal is to compare the efficacy of the standard of care (standard systemic therapy + definitive prostate-directed local therapy) versus the standard of care with metastasis-directed radiotherapy (MDRT) for consolidation of metastatic disease.
Conditions Studied
Interventions
- DRUG Androgen deprivation therapy (ADT)
- DRUG Androgen receptor signaling inhibitor (ARSI)
- OTHER Local Therapy: Radical Prostatectomy (RP) or Radiotherapy (RT)
- RADIATION Metastasis directed radiotherapy (MDRT)
Study Locations (2)
Ohio
- University Hospitals Cleveland Medical Center Seidman Cancer Center - Cleveland
Wisconsin
- Carbone Cancer Center University of Wisconsin-Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2028-04-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06150417
The ClinicalTrials.gov registry entry for NCT06150417 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (67% lower). The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Androgen deprivation therapy (ADT) is the first listed.
NCT06150417 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Ohio, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT06150417 about?
NCT06150417 is a clinical study titled "MDRT in Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)". The purpose of this study is to find out if giving radiation therapy (RT) to areas of metastatic prostate cancer at the time a participant is diagnosed will help control disease better than the usual treatment. This treatment is called metastasis-directed radiotherapy (MDRT). The usual treatment fo...
What is the current status of trial NCT06150417?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2024-07-01. Estimated completion is 2028-04-01.
What conditions does trial NCT06150417 study?
This clinical trial studies the following conditions: Prostate Cancer, Malignant Neoplasm of Prostate, Secondary Malignant Neoplasm of Prostate.
What interventions are being tested in trial NCT06150417?
The interventions under investigation include: Androgen deprivation therapy (ADT) (DRUG), Androgen receptor signaling inhibitor (ARSI) (DRUG), Local Therapy: Radical Prostatectomy (RP) or Radiotherapy (RT) (OTHER), Metastasis directed radiotherapy (MDRT) (RADIATION).
Who is sponsoring clinical trial NCT06150417?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06150417 being conducted?
This trial has 2 study locations across Ohio, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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