NCT06150417 · Case Comprehensive Cancer Center
MDRT in Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)
What this study 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).
View original scientific description
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).
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.
Primary outcome measures
Failure-free survival (FFS)
Time frame: Up to 5 years from treatment
Failure-free survival, defined as time from randomization to first evidence of at least one of: biochemical failure; progression either locally in lymph nodes, or in distant metastases; skeletal related event (where confirmed disease progression);any salvage intervention (local or systemic) required after 12m of planned SOC therapy; or death from prostate cancer. Biochemical failure, based on the PSA nadir in the first 24 weeks after randomization, is defined as at least one of: post-RT: 1. as per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3), where PSA must rise by ≥ 25% and ≥ 2ng/mL above nadir, confirmed by progression at two time points at least 3 weeks apart 2. post-RP: serum PSA nadir + 0.4 ng/mL, requiring confirmation ≥4 weeks later
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Newly diagnosed disease with no prior treatment(surgery, radiation or systemic treatment, ie hormone therapy or chemotherapy) to the primary disease.
- Participants may have started LHRH agonist or antagonist therapy, and/or androgen receptor signaling inhibitor (ARSI) as long as it was not started more than 30 days before the participant is enrolled on this study.
- In participants who undergo only conventional imaging, oligometastatic disease is defined as 1-5 discrete metastatic sites in the bone and/or extra-pelvic lymph node (LN) stations.
- Extra-pelvic LN stations are superior to the regional/pelvic LN stations. Pelvic LN stations commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins.
- Radiographic criteria for a LN to be considered a metastatic focus is defined as short-axis diameter in the axial plane of ≥ 1.0 cm, with irregular border and/or heterogeneous morphology
- In participants who undergo PSMA PET/CT (in the presence or absence of conventional imaging), oligometastatic disease is defined as 1-10 PSMA avid bone lesions and/or extra-pelvic LN stations. The MI-RADS reporting system will be followed to guide PSMA PET interpretation
- In participants extra-pelvic nodal (M1a) disease only by PSMA PET/CT and M0 by conventional imaging (i.e. extra-pelvic LN did not meet size criteria by CT), participant must meet 2 of 3 following criteria in order to be eligible:
- 1\. PSA ≥ 40
- 2\. Evidence of cN1 disease (pelvic LN)
- 3\. Decipher score ≥ 0.89
- Adequate organ and marrow function to receive treatment per treating physician
- Medically fit for treatment and agreeable to follow-up.
- Ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
- Participants with the presence of any of the following:
- 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.
- Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
- Prior definitive treatment to the primary prostate cancer or pelvis.
- Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes (HgA1c \> 10), active pituitary or adrenal dysfunction, or psychiatric illness/social situations that would limit compliance with study requirements
- History of another active malignancy within the previous 2 years, except for non-melanoma skin cancer, non-muscle invasive bladder cancer, or a malignancy that is considered cured with minimal risk of recurrence
- Active Crohn's disease or ulcerative colitis despite medical management.
- Refusal to sign informed consent.
- Any condition that in the opinion of the investigator would preclude participation in this study
Where
- New York, New York
- Cleveland, Ohio
- Madison, Wisconsin
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 15, 2026 · Source of record for eligibility and locations