Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06150417

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

Led by Case Comprehensive Cancer Center · Updated on 2025-11-12

200

Participants Needed

2

Research Sites

195 weeks

Total Duration

On this page

Sponsors

C

Case Comprehensive Cancer Center

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant must be 18 years of age or older.
  • Participant must have an ECOG performance status of 0 or 1.
  • Histologic confirmation of prostate adenocarcinoma with evidence of metastasis on imaging.
  • At least 10-15 unstained slides from 2 cores of highest tumor cellularity must be available.
  • Newly diagnosed prostate cancer with no prior treatment to the primary disease.
  • Participants may have started hormone therapy within 30 days before enrollment.
  • Oligometastatic disease defined as 1-5 metastatic sites by conventional imaging or 1-10 PSMA avid lesions by PSMA PET/CT.
  • In certain PSMA PET/CT cases with extra-pelvic nodal disease only, participant must meet 2 of 3 specific criteria (PSA ≥ 40, evidence of pelvic lymph node disease, or Decipher score ≥ 0.89).
  • Adequate organ and marrow function as per physician assessment.
  • Medically fit and willing to follow up.
  • Ability to understand and sign informed consent.
Not Eligible

You will not qualify if you...

  • Castration resistant prostate cancer.
  • Presence of visceral or intracranial metastases.
  • Receiving any other investigational cancer treatments.
  • Participating in another cancer treatment protocol.
  • Unable to lie flat or tolerate PET/MRI, PET/CT, or SBRT procedures.
  • Prior definitive treatment to the primary prostate cancer or pelvis.
  • Uncontrolled illnesses including active infection, heart failure, unstable angina, arrhythmia, uncontrolled diabetes, pituitary or adrenal dysfunction, or psychiatric/social issues limiting compliance.
  • History of another active malignancy within 2 years except certain low-risk cancers.
  • Active Crohn's disease or ulcerative colitis despite treatment.
  • Refusal to sign informed consent.
  • Any other condition that would preclude participation as judged by the investigator.

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Trial Site Locations

Total: 2 locations

1

University Hospitals Cleveland Medical Center Seidman Cancer Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

2

Carbone Cancer Center University of Wisconsin-Madison

Madison, Wisconsin, United States, 53792

Actively Recruiting

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Research Team

A

Angela Y Jia, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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