AzTrials
AzTrials

Prostate CancerPhase 2NCT06150417

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

A Phase 2 study testing Androgen deprivation therapy (ADT), Androgen receptor signaling inhibitor (ARSI) and Local Therapy: Radical Prostatectomy (RP) or Radiotherapy (RT) in people with Prostate Cancer and Malignant Neoplasm of Prostate, run by Case Comprehensive Cancer Center at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Androgen deprivation therapy (ADT), Androgen receptor signaling inhibitor (ARSI) and Local Therapy: Radical Prostatectomy (RP) or Radiotherapy (RT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
3 sitesUnited States
Study dates
1 Jul 2024to 1 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 17Show fewer
  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Angela Y Jia, MD, PhD contact

216-844-3262

Angela.Jia@UHhospitals.org

United States3 sites, 3 recruiting

  • University Hospitals Cleveland Medical Center Seidman Cancer Center

    Cleveland, Ohio, 44106

    Angela Y Jia, MD, PhD, 216-844-3262, Angela.Jia@UHhospitals.org

    Recruiting

  • Carbone Cancer Center University of Wisconsin-Madison

    Madison, Wisconsin, 53792

    Anthony Serritella, MD, 608-263-0786, serritella@medicine.wisc.edu

    Anthony Serritella, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    James Janopaul-Naylor, MD, 646-983-4738, janopaj@mskcc.org

    James Janopaul-Naylor, MD

    Recruiting

Other trials in United States

About this study

Official title: Metastasis-directed Radiotherapy (MDRT) for Men With De-novo Oligometastatic Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)

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.

Read the detailed description

Prostate cancer (PCa) is the most common cancer in men worldwide, with 10% diagnosed with metastatic disease at the time of presentation. The metastatic capacity of cancers behaves along a spectrum of disease progression, such that some solid tumors have spread widely before clinical detectability and others never metastasize. While metastatic disease has historically been treated with palliative intent, an oligometastatic state where metastases are limited in number and location has emerged in which participants with oligometastatic disease may benefit from effective local therapy in addition to systemic therapy. Systemic standard-of-care therapies often include androgen deprivation therapy (ADT) and Androgen receptor signaling inhibitor (ARSI). Studies have shown that administering local radiotherapy (RT) to the prostate in addition to standard of care may improve radiographic profession-free survival. It may be even more efficacious to add metastasis-directed radiotherapy (MDRT) to the treatment of oligometastatic prostate cancer cases. More research is necessary to investigate the application of MDRT to improve disease control.

Being tested
Androgen deprivation therapy (ADT), Androgen receptor signaling inhibitor (ARSI), Local Therapy: Radical Prostatectomy (RP) or Radiotherapy (RT), Metastasis directed radiotherapy (MDRT)
Keywords
Metastasis-directed Radiotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 groups in NCT06150417
Study groupRoleWhat they receive
Standard of Care (SOC)Active comparator* 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.
Receives: Drug: Androgen deprivation therapy (ADT); Drug: Androgen receptor signaling inhibitor (ARSI); Other: Local Therapy: Radical Prostatectomy (RP) or Radiotherapy (RT)
SOC + MDRTExperimental* 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.
Receives: Drug: Androgen deprivation therapy (ADT); Drug: Androgen receptor signaling inhibitor (ARSI); Other: Local Therapy: Radical Prostatectomy (RP) or Radiotherapy (RT); Radiation: Metastasis directed radiotherapy (MDRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Failure-free survival (FFS)

    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

    Measured: Up to 5 years from treatment

Secondary outcomes (16)

  1. Overall survival (OS)

    Overall Survival (OS) is defined as the time from randomization until death due to any cause. For participants who survive, time to death will be censored at the time of last contact. The distributions of OS for each treatment arm will be plotted using the Kaplan-Meier method, and median values for each will be estimated and reported with 95% CIs for each treatment arm and compared using stratified log-rank tests. Univariable Cox proportional hazard models will be used to estimate the effect of MDRT on OS.

    Measured: Up to 5 years from treatment

  2. Radiographic progression-free survival (rPFS)

    Radiographic progression-free survival (rPFS) is defined as the time from randomization until clinical progression, detection of at least one new metastatic lesion on CT, MRI, bone scan or Prostate Specific Membrane Antigen (PSMA) PET, or death from prostate cancer. The distributions of rPFS for each treatment arm will be plotted using the Kaplan-Meier method, and median values for each will be estimated and reported with 95% CIs for each treatment arm and compared using stratified log-rank tests. Univariable Cox proportional hazard models will be used to estimate the effect of MDRT on rPFS.

    Measured: Up to 5 years from treatment

  3. Time-to-next-intervention (TTNI)

    TTNI is defined as time-to-next-intervention. TTNI will be summarized in each arm and compared using Chi-square tests, as well as time-to-event analyses using cumulative incidence methods.

    Measured: Up to 5 years from treatment

  4. Time-to-castration-resistant prostate cancer

    The rate of time-to-castration-resistant prostate cancer will be summarized in each arm and compared using Chi-square tests, as well as time-to-event analyses using cumulative incidence methods.

    Measured: Up to 5 years from treatment

  5. Prostate-specific cancer mortality (PCSM)

    Prostate cancer specific mortality (PCSM) is defined the time from randomization to death directly attributable to prostate cancer, death from treatment complications, or death from unknown causes in participants with active prostate cancer or previously documented clinical or biochemical relapse.

    Measured: Up to 5 years from treatment

  6. Change in EPIC-26 Sexual Domain Score

    EPIC-26 is the validated short version of "The Expanded Prostate Cancer Index Composite". EPIC-26 will be administered as a health related quality of life questionnaire for participants with prostate cancer. EPIC-26 consists of 26 items under 5 domains. This study will analyze 4 of the domains, including the urinary, bowel, sexual, and hormonal domain. Each domain will be scaled, scored, and compared by arm.

    EPIC-26 assess participant function and bother on a qualitative scale which is then normalized on a scale of 0 to 100 (worst to best) to calculate individual domain scores.

    Measured: Baseline, 1 year after treatment

  7. Change in EPIC-26 Sexual Domain Score

    EPIC-26 is the validated short version of "The Expanded Prostate Cancer Index Composite". EPIC-26 will be administered as a health related quality of life questionnaire for participants with prostate cancer. EPIC-26 consists of 26 items under 5 domains. This study will analyze 4 of the domains, including the urinary, bowel, sexual, and hormonal domain. Each domain will be scaled, scored, and compared by arm.

    EPIC-26 assess participant function and bother on a qualitative scale which is then normalized on a scale of 0 to 100 (worst to best) to calculate individual domain scores.

    Measured: Baseline, 3 years after treatment

  8. Change in EPIC-26 Urinary Domain Score

    EPIC-26 is the validated short version of "The Expanded Prostate Cancer Index Composite". EPIC-26 will be administered as a health related quality of life questionnaire for participants with prostate cancer. EPIC-26 consists of 26 items under 5 domains. This study will analyze 4 of the domains, including the urinary, bowel, sexual, and hormonal domain. Each domain will be scaled, scored, and compared by arm.

    EPIC-26 assess participant function and bother on a qualitative scale which is then normalized on a scale of 0 to 100 (worst to best) to calculate individual domain scores.

    Measured: Baseline, 1 year after treatment

  9. Change in EPIC-26 Urinary Domain Score

    EPIC-26 is the validated short version of "The Expanded Prostate Cancer Index Composite". EPIC-26 will be administered as a health related quality of life questionnaire for participants with prostate cancer. EPIC-26 consists of 26 items under 5 domains. This study will analyze 4 of the domains, including the urinary, bowel, sexual, and hormonal domain. Each domain will be scaled, scored, and compared by arm.

    EPIC-26 assess participant function and bother on a qualitative scale which is then normalized on a scale of 0 to 100 (worst to best) to calculate individual domain scores.

    Measured: Baseline, 3 years after treatment

  10. Change in EPIC-26 Hormone Domain Score

    EPIC-26 is the validated short version of "The Expanded Prostate Cancer Index Composite". EPIC-26 will be administered as a health related quality of life questionnaire for participants with prostate cancer. EPIC-26 consists of 26 items under 5 domains. This study will analyze 4 of the domains, including the urinary, bowel, sexual, and hormonal domain. Each domain will be scaled, scored, and compared by arm.

    EPIC-26 assess participant function and bother on a qualitative scale which is then normalized on a scale of 0 to 100 (worst to best) to calculate individual domain scores.

    Measured: Baseline, 1 year after treatment

  11. Change in EPIC-26 Hormone Domain Score

    EPIC-26 is the validated short version of "The Expanded Prostate Cancer Index Composite". EPIC-26 will be administered as a health related quality of life questionnaire for participants with prostate cancer. EPIC-26 consists of 26 items under 5 domains. This study will analyze 4 of the domains, including the urinary, bowel, sexual, and hormonal domain. Each domain will be scaled, scored, and compared by arm.

    EPIC-26 assess participant function and bother on a qualitative scale which is then normalized on a scale of 0 to 100 (worst to best) to calculate individual domain scores.

    Measured: Baseline, 3 years after treatment

  12. Change in EPIC-26 Bowel Domain Score

    EPIC-26 is the validated short version of "The Expanded Prostate Cancer Index Composite". EPIC-26 will be administered as a health related quality of life questionnaire for participants with prostate cancer. EPIC-26 consists of 26 items under 5 domains. This study will analyze 4 of the domains, including the urinary, bowel, sexual, and hormonal domain. Each domain will be scaled, scored, and compared by arm.

    EPIC-26 assess participant function and bother on a qualitative scale which is then normalized on a scale of 0 to 100 (worst to best) to calculate individual domain scores.

    Measured: Baseline, 1 year after treatment

  13. Change in EPIC-26 Bowel Domain Score

    EPIC-26 is the validated short version of "The Expanded Prostate Cancer Index Composite". EPIC-26 will be administered as a health related quality of life questionnaire for participants with prostate cancer. EPIC-26 consists of 26 items under 5 domains. This study will analyze 4 of the domains, including the urinary, bowel, sexual, and hormonal domain. Each domain will be scaled, scored, and compared by arm.

    EPIC-26 assess participant function and bother on a qualitative scale which is then normalized on a scale of 0 to 100 (worst to best) to calculate individual domain scores.

    Measured: Baseline, 3 years after treatment

  14. Change in IPSS Score

    The "International Prostate Symptom Score" (IPSS) is an eight-question questionnaire that will be administered as a health related quality of life measure for participants with prostate cancer. The IPSS score is reported on a scale of 0 to 35. Scores are broken down as: "Mild" (0 to 7 points), "Moderate" (8 to 19 points), and "Severe" (20 to 35 points). The change in IPSS score from baseline prior to treatment to one year after treatment will be measured.

    Measured: Baseline, 1 year after treatment

  15. Change in IPSS Score

    The "International Prostate Symptom Score" (IPSS) is an eight-question questionnaire that will be administered as a health related quality of life measure for participants with prostate cancer. The IPSS score is reported on a scale of 0 to 35. Scores are broken down as: "Mild" (0 to 7 points), "Moderate" (8 to 19 points), and "Severe" (20 to 35 points). The change in IPSS score from baseline prior to treatment to three years after treatment will be measured.

    Measured: Baseline, 3 year after treatment

  16. Skeletal-related events (SRE)

    Time to the first skeletal-related event is defined as the time from randomization to the first new pathological bone fracture, spinal cord compression, tumor-related orthopedic surgery, and radiation therapy for bone pain. The SRE will be summarized in each arm and compared using Chi-square tests, as well as time-to-event analyses using cumulative incidence methods. The univariable generalized linear models (e.g., Poisson or negative binomial model) will be used to quantify the MDRT effect on the frequency of SRE.

    Measured: 5 years after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2023
  2. Study start1 Jul 2024
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase II non-blinded randomized study evaluating men with de novo oligometastatic prostate cancer randomized (1:1) to standard of care (SOC) versus SOC plus MDRT.
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06150417
Sponsor's protocol ID
CASE5823
Other IDs
U01CA257638
Status last verified
Sep 2026
First submitted
21 Nov 2023
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in publication.

Publications

  • Lichtman-Mikol S, Lang JM, Nagar H, Zuhour R, Chaung KV, Zaorsky NG, Roy S, Mendiratta PM, Shoag JE, Janopaul-Naylor JR, Khani F, Schaeffer EM, Kyriakopoulos CE, Barata P, Brown JR, Garcia JA, Barbieri CE, Sun Y, Choyke PL, Spratt DE, Jia AY. Metastasis-directed radiotherapy (MDRT) for men with de novo, oligometastatic prostate cancer treated with long-term androgen deprivation therapy in the STAMPEDE trial (METANOVA): protocol for a multicentre, phase II randomised controlled trial in the USA. BMJ Open. 2026 Oct 6;16(10):e116331. doi: 10.1136/bmjopen-2026-116331.

    PubMed 42838582

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Androgen deprivation therapy (ADT), Androgen receptor signaling inhibitor (ARSI) and Local Therapy: Radical Prostatectomy (RP) or Radiotherapy (RT) in people with Prostate Cancer and Malignant Neoplasm of Prostate, run by Case Comprehensive Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Angela Y Jia, MD, PhD (216-844-3262, Angela.Jia@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failure-free survival (FFS) (time frame: Up to 5 years from treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06150417, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in