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Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer

MC230504 Safe Omission of Pelvic Lymph Node Dissection (SOuND ) During Radical Prostatectomy: Diagnostic Accuracy of rhPSMA-7.3(18F) PET/CT, mpMRI and Patient Clinical Factors to Predict Lymph Node Metastasis

Who can join

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

Age
30 Years to 85 Years
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

  • Procedures mentioned: CT scans, MRI scans

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
  • "Prostate specific membrane antigen (PSMA) PET/computed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients."
  • "MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body."
  • "Patients also undergo CT/MRI or bone scan/PET, as well as tissue collection during screening."
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 how well an 18F-rhPSMA-7.3 PET/MRI scan can predict prostate cancer spread to lymph nodes, small parts of the body's immune system. It is for men with high-risk prostate cancer who plan to have surgery to remove the prostate and nearby lymph nodes.

This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \[PET\]/magnetic resonance imaging \[MRI\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET/computed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET/CT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET/ MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy.

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

Eligibility

Who can join

  • Men ages 30 to 85.
  • Have newly diagnosed, untreated, high-risk prostate cancer in the prostate area, confirmed by MRI with contrast dye and a tissue sample.
  • Have not had hormone treatment for prostate cancer.
  • Plan to have surgery to remove the prostate and an extended group of lymph nodes in the pelvis.
  • Have no more than 3 lymph nodes showing cancer on standard scans of the prostate area done within 6 months before surgery.
  • Agree to follow the study doctor's instructions and follow-up visit schedule.
  • Can give full written consent to join.

Who can't join

  • Plan to have cancer treatment before surgery, or are scheduled for chemotherapy, radiation, hormone treatment, or open surgery during the study.
  • Have used immune-suppressing drugs, including steroids that affect the whole body, for more than 2 weeks; had cell-killing chemotherapy within 1 month before screening; or receive or expect to need these drugs during screening or the study.
  • Had hormone treatment, such as Lupron or drugs that block male hormones, within 12 weeks before signing up.
  • Have more than 3 lymph nodes showing cancer on standard scans before surgery, or have had radiation to the pelvis.
  • Have a body mass index (BMI), a measure of weight compared with height, over 40; or had keyhole surgery with mesh to repair a groin hernia.
  • Cannot lie still for the 75-minute scan, or have a brain, nerve, or mental health condition that could affect checks after surgery.
  • Have a condition that seriously limits taking part or giving consent, or a known history of not following medical treatment.
  • Received an experimental drug within 30 days before signing up, or plan to receive another experimental product or procedure during the study.

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

Official eligibility criteria

Inclusion Criteria: * Male subjects ≥ 30 and ≤ 85 years old * Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy with extended lymph node dissection) * Primary diagnosis of untreated American Urological Association (AUA) guidelines high-risk localized prostate cancer, hormone-naïve prostate cancer via contrast enhanced prostate MRI + tissue sampling * Planned elective radical prostatectomy with extended pelvic lymph node dissection * Clinical oligometastatic disease with ≤ 3 nodes positive on preoperative standard of care imaging of prostate region within 6 months of surgery * Patient agrees to comply with the investigator instructions * Patient agrees to comply with the follow-up surveillance schedule * Have ability to provide full written consent Exclusion Criteria: * High-risk cancer planned for neoadjuvant therapy * Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study * Patients that have had prior hormonal therapy such as Lupron or oral antiandrogens ≤ 12 weeks prior to registration * Clinical oligometastatic disease with \> 3 nodes positive preoperative standard of care imaging of prostate region * Previous history of pelvic radiation * Patients with obesity defined as body mass index (BMI) \> 40 kg/m\^2 * History of prior laparoscopic inguinal hernia repair with mesh * Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period * Inability to lie still for 75 minutes during 18F-rhPSMA-7.3 PSMA PET-MRI imaging * Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments * Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment * Received administration of an investigational drug within 30 days prior to study registration, and/or has planned administration of another investigational product or procedure during participation in this study

Study sites (1)

FL