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NCT Number: NCT07807293

Radioguided Salvage Pelvic Node Dissection in Oligometastatic Prostate Cancer - SALVAGE

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.

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Key information

Conditions

Prostate Cancer Disease Attributes Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Oligometastatic Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Recurrence Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Salvage pelvic lymph node dissection

Other

Salvage standard lymph node dissection

Primary outcomes

  1. Pathologic metastatic yield

    Time frame: 2-4 weeks post-op

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

Secondary outcomes

  1. PSMA PET/CT and pathologic node concordance

    Time frame: 2-4 weeks post-op

    Concordance between pre-operative PSMA-PET/CT-identified nodal lesions and histopathological confirmation of metastatic lymph nodes, evaluated at the nodal region level and, where feasible, at the individual node level.

  2. Biochemical response at Week 6

    Time frame: Surgery to 6 week post-op

    • Biochemical control considered as PSA level <0.2 after primary prostatectomy
    • Biochemical control considered as PSA level <2 above nadir after primary radiotherapy
    • Proportion of participants achieving PSA decline >50%
    • Proportion of participants achieving PSA decline >90%

  3. Patient-reported quality-of-life outcomes

    Time frame: Date of surgery until 2 years post-operative

    Patient-reported health-related quality of life will be assessed using the Expanded Prostate Cancer Index Composite 26-item short form (EPIC-26). The EPIC-26 produces five domain scores: urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Each domain score ranges from 0 to 100, with higher scores indicating better function and health-related quality of life (fewer symptoms or less bother).

    Outcomes will include:

    • Change from baseline in each EPIC-26 domain score at each follow-up timepoint.
    • Between-group differences in EPIC-26 domain scores over time.
    • Proportion of participants experiencing clinically meaningful deterioration in each domain, defined as a decrease from baseline meeting a prespecified, validated minimally important difference (6-9 points for urinary incontinence, 5-7 for urinary irritative/obstructive, 4-6 for bowel, 10-12 for sexual, and 4-6 for hormonal scores)

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

    Time frame: Surgery to 2 years post-operative

    • Time to PSA failure (biochemical failure), defined as time from sLND to first occurrence of PSA failure (confirmed rise above nadir/threshold)
    • Time to recurrence-directed imaging prompted by biochemical and/or clinical suspicion
    • Time to initiation of salvage treatment, defined as time from sLND to start of first salvage therapy for recurrent/progressive disease, such as salvage radiotherapy and/or systemic therapy (ADT ± ARPI/other systemic agents)
    • Metastasis-free survival (MFS), defined as time from sLND to first evidence of distant metastasis on imaging following standard-of-care principles or death from any cause, whichever occurs first

Other outcomes

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

    Time frame: Surgery until 2 years post-operative

    • Proportion of participants with in-field nodal recurrence, defined as PSMA-avid lymph nodes within the prior surgical dissection template
    • Proportion of participants with out-of-field regional recurrence, defined as PSMA-avid pelvic or paraaortic nodes outside the prior dissection template
    • Proportion of participants with distant recurrence, defined as extra-pelvic nodal, osseous, or visceral PSMA-avid lesions

  2. Disease burden at biochemical persistence:

    Time frame: Surgery until 2 years post-operative

    -Number of PSMA-avid lesions per participant on PSMA-PET/CT, compared descriptively between treatment arms

  3. PSMA-PET/CT detection rate at biochemical persistence:

    Time frame: Surgery until 2 years post-operative

    -Proportion of participants with at least one PSMA-avid lesion identified on PSMA-PET/CT

Study contacts

Contact information is provided by the study sponsor or research team.

Miles P Mannas, MD, MSc, FRCSC

CONTACT

[email protected]

604-875-5003

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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)

Acronym: SALVAGE

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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