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RECRUITING
NCT06150417
PHASE2

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

Sponsor: Case Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-07-01

Completion Date

2028-04-01

Last Updated

2025-11-12

Healthy Volunteers

No

Interventions

DRUG

Androgen deprivation therapy (ADT)

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

DRUG

Androgen receptor signaling inhibitor (ARSI)

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

OTHER

Local 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

RADIATION

Metastasis 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