RecruitingPhase 2NCT06150417

MDRT in Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)

Metastasis-directed Radiotherapy (MDRT) for Men With De-novo Oligometastatic Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)


Sponsor

Case Comprehensive Cancer Center

Enrollment

200 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (METANOVA) is studying whether targeted radiation therapy to metastatic lesions (called metastasis-directed radiation therapy, or MDRT) in addition to standard hormone-blocking treatment can improve outcomes in men with newly diagnosed, oligometastatic prostate cancer (cancer that has spread to a limited number of spots). It is part of the larger STAMPEDE trial program. **You may be eligible if...** - You are 18 years or older with newly diagnosed prostate cancer that has spread to 1–10 sites (bones or lymph nodes outside the pelvis) - Your cancer has not been previously treated (surgery, radiation, or systemic therapy), although you may have recently started hormone therapy within the past 30 days - You are in good health (ECOG performance status 0–1) and able to lie still during radiation **You may NOT be eligible if...** - You have castration-resistant prostate cancer (cancer that grows despite hormone therapy) - Your cancer has spread to organs (visceral metastases) or the brain - You are already in another cancer treatment trial - You have had prior treatment for your prostate cancer - You have active Crohn's disease or ulcerative colitis - You have significant heart disease, uncontrolled diabetes, or other serious conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAndrogen deprivation therapy (ADT)

Standard androgen deprivation therapy (ADT) will be administered at the discretion of treating physician.

DRUGAndrogen receptor signaling inhibitor (ARSI)

Standard androgen receptor signaling inhibitors (ARSI) will be administered at the discretion of the treating physician.

OTHERLocal Therapy: Radical Prostatectomy (RP) or Radiotherapy (RT)

Local therapy will either be radiotherapy (RT) or radical prostatectomy (RP). * Prostate +/- pelvic nodal radiation * Radical prostatectomy + pelvic lymph node dissection

RADIATIONMetastasis directed radiotherapy (MDRT)

In participants randomized to the MDRT arm, MDRT to all lesions will be performed by the end of Week 24. Selection of a particular regimen (the dose and fractionation) will based on the size and location of the participant's metastatic site and the surrounding normal tissue constraints.


Locations(2)

University Hospitals Cleveland Medical Center Seidman Cancer Center

Cleveland, Ohio, United States

Carbone Cancer Center University of Wisconsin-Madison

Madison, Wisconsin, United States

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NCT06150417


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