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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT06150417
Phase
PHASE2
Status
Recruiting
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Conditions

  • Malignant Neoplasm of Prostate
  • Prostate Cancer
  • Secondary Malignant Neoplasm of Prostate

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Androgen deprivation therapy (ADT) — DRUG
    Standard androgen deprivation therapy (ADT) will be administered at the discretion of treating physician.
  • Androgen receptor signaling inhibitor (ARSI) — DRUG
    Standard androgen receptor signaling inhibitors (ARSI) will be administered at the discretion of the treating physician.
  • Local Therapy: Radical Prostatectomy (RP) or Radiotherapy (RT) — OTHER
    Local therapy will either be radiotherapy (RT) or radical prostatectomy (RP). * Prostate +/- pelvic nodal radiation * Radical prostatectomy + pelvic lymph node dissection
  • Metastasis directed radiotherapy (MDRT) — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Nov 2025
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care (SOC)
    * Participants will receive the standard of care. Standard systemic therapy (SST) and definitive local therapy (radiotherapy \[RT\] or radical prostatectomy \[RP\]) are the standard of care for de novo oligometastatic prostate cancer. This arm will be used to compare to the experimental arm. * SST will begin 6 weeks of randomization and occur for 12 months. The definitive local therapy will be RT, with a small portion undergoing RP. Local therapy should be completed by the end of Week 20.
  • Experimental: SOC + MDRT
    * Participants will receive the standard of care. Standard systemic therapy (SST) and definitive local therapy (radiotherapy \[RT\] or radical prostatectomy \[RP\]) are the standard of care for de novo oligometastatic prostate cancer. This arm will be used to compare to the experimental arm. * SST will begin 6 weeks of randomization and occur for 12 months. The definitive local therapy will be RT, with a small portion undergoing RP. Local therapy should be completed by the end of Week 20. * MDRT should be completed by the end of Week 24. Depending on the participant, there are different approaches to MDRT dosing and fraction size.

Primary Outcome Measure

Failure-free survival (FFS) [ Time Frame: Up to 5 years from treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical Center Seidman Cancer CenterClevelandOhio44106
Angela Y Jia, MD, PhD
[email protected]
216-844-3262
Carbone Cancer Center University of Wisconsin-MadisonMadisonWisconsin53792
Christos Kyriakopoulos, MD
[email protected]
608-263-0786
Christos Kyriakopoulos, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University Hospitals Cleveland Medical Center Seidman Cancer Center· Cleveland, OHCarbone Cancer Center University of Wisconsin-Madison· Madison, WI

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