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RecruitingEarly Phase 1

rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance

A Pilot Study of rhPSMA-PET MRI Imaging for the Detection of Clinically Actionable Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance

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
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

  • Procedures mentioned: MRI scans, PET scans, Biopsies

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
  • "This clinical trial evaluates whether positron emission tomography-magnetic resonance imaging (PET-MRI) using the radioactive drug radiohybrid prostate-specific membrane antigen (rhPSMA)-7.3 may help in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer who are candidates for active surveillance."
  • "A PET scan is a test that uses a radioactive drug and a computer to create images of how organs and tissues in the body are functioning."
  • "An MRI scan uses strong magnets and computers to create detailed images of the soft tissue in your body."
  • "A multiparametric (mp)MRI is a type of MRI scan that creates a more detailed picture of the prostate gland."
  • "Measure the rate of rhPSMA-7.3-PET-MRI identified Gleason Grade Group (GG) 3-5 disease on pathology or locally advanced disease."
  • "Determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for rhPSMA-PET-MRI to detect prostate cancer in the prostate stratified by Gleason Grade Groups."
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 PET-MRI scans with the radioactive drug rhPSMA-7.3, along with detailed prostate MRI scans, can find more serious prostate cancer. It is for men with low-risk or favorable intermediate-risk prostate cancer who could choose active surveillance—closely watching the cancer instead of treating it right away.

This clinical trial evaluates whether positron emission tomography-magnetic resonance imaging (PET-MRI) using the radioactive drug radiohybrid prostate-specific membrane antigen (rhPSMA)-7.3 may help in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer who are candidates for active surveillance. A PET scan is a test that uses a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. The radioactive drug used in this study, rhPSMA-7.3, attaches to the abnormal cells in the body at a different rate than normal cells which allows the scanner to create a detailed picture of how the body is working. An MRI scan uses strong magnets and computers to create detailed images of the soft tissue in your body. A multiparametric (mp)MRI is a type of MRI scan that creates a more detailed picture of the prostate gland. Using rhPSMA-73 with PET-MRI and mpMRI may be more effective in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer.

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

Eligibility

Who can join

  • Men age 18 or older who are fully active or have only limits on hard physical activity, and are expected to live at least 10 more years.
  • A tissue test must show prostate adenocarcinoma, a type of prostate cancer, in Gleason Grade Group 1 or 2.
  • The last biopsy showing cancer must have been 3–15 months before screening. It must have taken at least 10 tissue samples and used information from an earlier detailed prostate MRI.
  • The cancer must meet the study's rules for low risk or favorable intermediate risk, based on its size and spread, grade, and PSA blood test level.
  • A prior biopsy must have a Decipher score of at least 0.45. This gene test helps assess the cancer's risk.
  • Must understand the study and be willing to sign a written consent form before joining and before any study procedures.
  • Must agree to a prostate biopsy within 90 days of the PET-MRI scan and before any prostate cancer treatment that does not involve surgery.
  • Other illnesses and cancers are allowed.

Who can't join

  • Past radiation, surgery, chemotherapy, or hormone treatment for prostate cancer.
  • Prostate cancer in the very-low-risk group under the study's rules.
  • A Decipher gene test score below 0.45.
  • A past procedure to improve urine flow through the prostate, such as HoLEP, TURP, UroLift, or Rezum.
  • Use of a 5-alpha reductase inhibitor, a type of prostate medicine, or testosterone-lowering treatment such as leuprolide or relugolix within 1 month before screening.
  • A condition or device that could make MRI unsafe, such as a pacemaker.
  • A past hip replacement.
  • An experimental treatment too close to screening: within 28 days or within five half-lives of the treatment, whichever is longer. A half-life is the time it takes for half of a drug to leave the body.

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

Official eligibility criteria

Inclusion Criteria: * Healthy men (Eastern Cooperative Oncology Group \[ECOG\] 0-1), \>= 18 years old with at least 10 year life expectancy * Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate * Last prostate cancer containing biopsy performed within 3-15 months (mo.) prior to screening. Biopsy must have been \>= 10 core biopsy and informed by prior mpMRI * Prostate cancer categorized as low risk or favorable risk by National Comprehensive Cancer Network (NCCN) criteria (low risk is defined as T1c-T2a, prostate-specific antigen \[PSA\] \< 10ng/ml, Gleason Grade Group 1 \[Gleason 3+3=6\] disease) and favorable intermediate risk as having no more than one of the following intermediate risk features, clinical T2b-T2c disease, PSA 10-20ng/ml, Gleason Grade Group 2 \[Gleason score 3+4=7\]) * Decipher genomic classifier score from prior biopsy \>= 0.45 * Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures * Concurrent diseases and malignancies are permitted * Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study * Willing to undergo prostate biopsy prior to non-surgical treatment of prostate cancer and within 90 days of PET-MRI imaging Exclusion Criteria: * Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer * NCCN very low risk category (T1c and Gleason Grade Group 1 \[Gleason score 3+3=6\], PSA \< 10 ng/mL, fewer than 3 prostate biopsy cores positive, =\< 50% cancer in any core, PSA density \< 0.15 ng/mL/g) * Decipher score \< 0.45 * Prior bladder outlet procedure (i.e,. holmium laser enucleation of the prostate \[HoLEP\], transurethral resection of the prostate \[TURP\], Urolift, Rezum) * Prohibited medications: use of 5 alpha reductase inhibitor or androgen deprivation therapy (i.e., leuprolide, relugolix) within 1 month of screening * Contra-indication or relative contra-indication to MRI (i.e., pacemaker) * History of hip replacement * Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening

Study sites (1)

IL