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

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

• Prostate Cancer
• Malignant Neoplasm of Prostate
• Secondary 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.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Case Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Angela Y Jia, MD, PhD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

• Daniel E Spratt, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-01

Primary Completion

2028-04-01

Completion

2028-04-01

FDA Drug

Yes

Countries

• United States

Study Locations