Radioguided Salvage Pelvic Node Dissection in Oligometastatic Prostate Cancer - SALVAGE

NCT07807293 | Not Yet Recruiting Phase 2

• 1 other identifier: H26-01861
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prostate Cancer; Oligometastatic

Keywords

prostate cancer; PSMA; radioguided surgery; olgiometastasis; Recurrent

Outcome Measures

Primary Outcomes (1)

• Pathologic metastatic yield

  The ratio of metastatic (histopathologically confirmed) lymph nodes to the total number of lymph nodes removed during salvage lymph node dissection.

  2-4 weeks post-op

Secondary Outcomes (4)

• PSMA PET/CT and pathologic node concordance

  2-4 weeks post-op

• Biochemical response at Week 6

  Surgery to 6 week post-op

• Patient-reported quality-of-life outcomes

  Date of surgery until 2 years post-operative

• Long-term biochemical and clinical outcomes at 2 years post-lymph node dissection

  Surgery to 2 years post-operative

Other Outcomes (3)

• Pattern of recurrence on PSMA-PET/CT at first biochemical recurrence/persistence

  Surgery until 2 years post-operative

• Disease burden at biochemical persistence:

  Surgery until 2 years post-operative

• PSMA-PET/CT detection rate at biochemical persistence:

  Surgery until 2 years post-operative

Study Arms (2)

Salvage pelvic lymph node dissection

ACTIVE COMPARATOR

Salvage radioguided pelvic lymph node dissection

Other: Salvage pelvic lymph node dissection

PSMA technetium assisted radioguided salvage lymph node dissection

EXPERIMENTAL

Participants will be administered PSMA technetium pre-operatively to assess effect of radioguided lymph node dissection on oncologic, quality of life and functional outcomes

Procedure: PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection

Interventions

Salvage pelvic lymph node dissection OTHER

Salvage standard lymph node dissection

Salvage pelvic lymph node dissection

PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection PROCEDURE

Participants in the intervention arm will receive PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection.

PSMA technetium assisted radioguided salvage lymph node dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Miles P Mannas, MD, MSc, FRCSC

CONTACT

604-875-5003; miles.mannas@ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, open-label, two-arm, parallel-group Phase II clinical trial.

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 8, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: September 8, 2026

Record last verified: 2026-09