Study on Radiation Therapy and Hormone Treatment for Metastatic Prostate Cancer in the STAMPEDE Trial (METANOVA)

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06150417

Provider View

This clinical trial is exploring whether adding radiation therapy to areas where prostate cancer has spread can better control the disease compared to the usual hormone therapy treatment. The study involves hormone therapy, radiation therapy, and possibly surgery, with follow-up care for up to five years.

Patient Parameters

Program Overview

The study aims to determine if using radiation therapy (RT) on areas where prostate cancer has spread can improve disease control compared to the standard treatment. Typically, prostate cancer that has spread is treated with lifelong hormone therapy, also known as androgen deprivation therapy (ADT). Participants in this study will receive hormone therapy for 12 months, which can be taken as pills or injections, and will also undergo prostate RT. Some participants may have surgery to remove the prostate instead of RT. A portion of participants will receive additional radiation therapy directed at the cancer spread areas. Those who have surgery will be asked to provide tissue samples for research. The study will last about 12 months, with follow-up care for up to five years.

Description

Prostate cancer is the most common cancer in men worldwide, and about 10% of cases are metastatic at diagnosis, meaning the cancer has spread to other parts of the body. While metastatic cancer is often treated to relieve symptoms, some cases with limited spread, known as oligometastatic disease, may benefit from targeted local treatments in addition to standard hormone therapy. This study investigates whether adding radiation therapy to areas where the cancer has spread can improve outcomes for patients with oligometastatic prostate cancer. Participants will receive standard hormone therapy and may also receive radiation therapy to the prostate and areas of cancer spread. The study will compare the effectiveness of standard treatment alone versus standard treatment with additional radiation therapy.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have confirmed prostate adenocarcinoma with evidence of metastasis on imaging tests.
  • Must have newly diagnosed disease with no prior treatment to the primary cancer.
  • Must have started hormone therapy within the past 30 days before joining the study.
  • Must have 1-5 metastatic sites in the bone or lymph nodes outside the pelvis, as seen on conventional imaging.
  • Must have 1-10 PSMA avid bone lesions or lymph nodes outside the pelvis, as seen on PSMA PET/CT.
  • Must have adequate organ and marrow function to receive treatment.
  • Must be medically fit for treatment and agree to follow-up care.
  • Must understand and agree to sign a written informed consent.

Exclusion Criteria

  • Have castration-resistant prostate cancer.
  • Have cancer spread to organs or the brain.
  • Are receiving other investigational cancer treatments.
  • Are participating in another cancer treatment study.
  • Cannot lie flat or tolerate imaging tests or radiation therapy.
  • Have had prior definitive treatment to the prostate or pelvis.
  • Have uncontrolled health conditions, such as infections, heart problems, or diabetes.
  • Have had another active cancer within the past two years, except for non-melanoma skin cancer.
  • Have active Crohn's disease or ulcerative colitis despite treatment.
  • Refuse to sign informed consent.
  • Have any condition that the investigator believes would prevent participation in the study.

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