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

PHASE2RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

April 1, 2028

Study Completion Date

April 1, 2028

Conditions
Prostate CancerMalignant Neoplasm of ProstateSecondary Malignant Neoplasm of Prostate
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.

Trial Locations (2)

44106

RECRUITING

University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland

53792

NOT_YET_RECRUITING

Carbone Cancer Center University of Wisconsin-Madison, Madison

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

lead

Case Comprehensive Cancer Center

OTHER