RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months, 5 years
  • Procedures mentioned: Injections, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding radiation to places where prostate cancer has spread helps control it better than usual care alone. It is for adults with newly diagnosed prostate cancer that has spread to a limited number of places. Usual care in this study includes hormone therapy and radiation to the prostate, or surgery for some people.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and able to do most daily activities with little or no help.
  • Have prostate cancer confirmed by a tissue test, with scans showing that it has spread. Required tissue samples must be available.
  • Have newly diagnosed cancer with no past treatment, except certain hormone drugs started no more than 30 days before joining.
  • Have spread only to bones or lymph nodes outside the pelvis: 1–5 sites on standard scans or 1–10 sites on a PSMA PET/CT, a special cancer scan.
  • If only the special scan shows spread to lymph nodes outside the pelvis, meet 2 of these 3 rules: PSA blood test of at least 40, cancer in pelvic lymph nodes, or Decipher tumor test score of at least 0.89.
  • Have organs and bone marrow working well enough for treatment, as judged by your doctor.
  • Be well enough for treatment and agree to follow-up visits.
  • Be able to understand the study and sign a form agreeing to take part.

Who can't join

  • Have prostate cancer that keeps growing despite treatment to lower male hormones, or cancer that has spread to internal organs or inside the skull.
  • Receive another experimental cancer drug or take part in another cancer treatment study.
  • Be unable to lie flat or handle the required scans or focused radiation treatment.
  • Have already had treatment aimed at removing or destroying the cancer in the prostate or pelvis.
  • Have an uncontrolled illness, such as infection, heart disease, diabetes, or hormone gland problems, or mental health or social problems that make study requirements hard to follow.
  • Have had another active cancer in the past 2 years, except certain skin cancers, bladder cancer that has not reached muscle, or cancer considered cured with little risk of returning.
  • Have active Crohn’s disease or ulcerative colitis—conditions that cause swelling in the bowel—despite treatment.
  • Refuse to sign the consent form, or have any condition the study doctor believes would prevent you from taking part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (3)

NY

OH

WI