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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorCase Comprehensive Cancer Center

About this trial

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 criteria

Qualifiers

Participant must be ≥ 18 years of age.

Participant must have an ECOG performance status ≤ 1.

Histologic confirmation of prostate adenocarcinoma of the prostate gland, with evidence of metastasis on imaging by conventional imaging (MRI, CT, or 99mTc bone scan) or PSMA PET/CT. Biopsy of sites of metastasis is strongly encouraged, but not required.

There must be at least 10-15 unstained slides from 2 cores of the highest tumor cellularity available.

Disqualifiers

Castration resistant prostate cancer (CRPC).

Evidence of visceral or intracranial metastases.

Participant receiving any other investigational agents for cancer.

Participant is participating in a concurrent treatment protocol for cancer.

Trial design

Treatments tested in this trial

  • Androgen deprivation therapy (ADT)
  • Androgen receptor signaling inhibitor (ARSI)
  • Local Therapy: Radical Prostatectomy (RP) or Radiotherapy (RT)
  • Metastasis directed radiotherapy (MDRT)

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Case Comprehensive Cancer Center

Lead sponsor

National Institutes of Health (NIH)

Collaborator