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METANOVA Study: Metastasis-Directed Radiotherapy for Prostate Cancer

This study, called METANOVA, is looking at whether adding radiation therapy directly to areas where prostate cancer has spread (metastasis-directed radiotherapy or MDRT) can better control the disease. This is being compared to the usual treatment for prostate cancer that has spread, which involves long-term hormone therapy (androgen deprivation therapy or ADT) and sometimes radiation to the prostate itself. You would receive standard hormone therapy for 12 months, which can be pills or injections, and prostate radiation. If you are in the MDRT group, you would also receive radiation to all metastatic sites within 24 weeks. The study is open to men aged 18 or older with prostate cancer that has spread, and who have a good general health status (ECOG performance status ≤ 1). Success in this study will be measured by how long participants live without their cancer getting worse (failure-free survival), for up to 5 years. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 200 participants. It is comparing standard treatments with the addition of metastasis-directed radiotherapy (MDRT).
What's involved
Participants will receive hormone therapy (androgen deprivation therapy or ADT) for 12 months and prostate radiation. If in the MDRT group, you would also receive radiation to metastatic sites by Week 24.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for failure-free survival for up to 5 years from treatment.

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NCT06150417

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Case Comprehensive Cancer Center
~200 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Androgen deprivation therapy (ADT)Androgen receptor signaling inhibitor (ARSI)Local Therapy: Radical Prostatectomy (RP) or Radiotherapy (RT)Metastasis directed radiotherapy (MDRT)

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Failure-free survival (FFS)
Measured over Up to 5 years from treatment

Conditions

Prostate Cancer
Malignant Neoplasm of Prostate
Secondary Malignant Neoplasm of Prostate

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Where it's being run

3 sites across 3 states
New York1
Ohio1
Wisconsin1

Study leadership

  • Angela Y Jia, MD, PhD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
  • Daniel E Spratt, MD · STUDY_CHAIR · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Who to contact

Angela Y Jia, MD, PhD
[email protected]
216-844-3262
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Failure-free survival (FFS)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