Radioguided Salvage Pelvic Node Dissection in Oligometastatic Prostate Cancer - SALVAGE

Radioguided SALVAGE Lymph Node Dissection In Oligometastatic Prostate Cancer: A Prospective Randomized controLled Trial Comparing 99mTc-PSMA-radioguided Salvage Lymph Node Dissection With PSMA-PET Based Lymph Node Dissection (The SALVAGE Study)

The goal of this clinical trial is to learn whether radioguided surgery can help surgeons find and remove lymph nodes containing prostate cancer in men whose cancer has returned in a small number of lymph nodes after previous prostate cancer treatment. It will also learn about the safety of this approach, changes in prostate-specific antigen (PSA), quality of life, and longer-term cancer outcomes.

The main questions the study aims to answer are:

Does radioguided surgery increase the proportion of removed lymph nodes that are found to contain prostate cancer compared with standard surgery? How well do the lymph nodes identified on imaging scans match the cancer found when the removed lymph nodes are examined in the laboratory? Does radioguided surgery lead to a greater decrease in PSA after surgery? What side effects or surgical complications occur? How does each type of surgery affect quality of life, the need for additional cancer treatment, and the risk of the cancer spreading? Researchers will compare radioguided salvage lymph node surgery with standard salvage lymph node surgery. Salvage lymph node surgery is an operation to remove lymph nodes after prostate cancer has returned.

Participants will:

Be randomly assigned to one of two treatment groups. Have surgery to remove lymph nodes suspected of containing prostate cancer. If assigned to the radioguided group, receive a radioactive PSMA-targeting tracer called 99mTc-MIP-1404, undergo a SPECT/CT scan, and have surgery the following day. During surgery, the surgeon will use a handheld detector to locate lymph nodes that have taken up the tracer.

If assigned to the standard-surgery group, have surgery planned using a standard PSMA-PET/CT scan, without the handheld radioguidance procedure.

Have PSA blood tests, assessments for complications, and quality-of-life questionnaires after surgery.

Be followed for cancer outcomes for up to two years.

Inclusion Criteria:

• Adult
• Males
• Oligorecurrent prostate cancer following definitive treatment who demonstrate a maximum of four positive lymph nodes within no more than three nodal basins on 68Ga-PSMA-PET/CT Considered suitable candidates for salvage surgery.

Exclusion Criteria:

• Not meeting inclusion criteria