Prostate CancerPhase 2SALVAGENCT07807293
Radioguided Salvage Pelvic Node Dissection in Oligometastatic Prostate Cancer - SALVAGE
A Phase 2 study testing PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection and Salvage pelvic lymph node dissection in people with Prostate Cancer and Oligometastatic, run by University of British Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Oligometastatic
- What is being tested?
- PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection and Salvage pelvic lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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)
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:
Read more
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
- Being tested
- PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection, Salvage pelvic lymph node dissection
- Keywords
- prostate cancer, PSMA, radioguided surgery, olgiometastasis, Recurrent
- Medical subject headings
- Prostatic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissectionProcedure or surgery
Participants in the intervention arm will receive PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection.
Salvage pelvic lymph node dissectionOther
Salvage standard lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Salvage pelvic lymph node dissection | Active comparator | Salvage radioguided pelvic lymph node dissection Receives: 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 Receives: Procedure: PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic metastatic yield
The ratio of metastatic (histopathologically confirmed) lymph nodes to the total number of lymph nodes removed during salvage lymph node dissection.
Measured: 2-4 weeks post-op
Secondary outcomes (4)
PSMA PET/CT and pathologic node concordance
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.
Measured: 2-4 weeks post-op
Biochemical response at Week 6
- 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%
Measured: Surgery to 6 week post-op
Patient-reported quality-of-life outcomes
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)
Measured: Date of surgery until 2 years post-operative
Long-term biochemical and clinical outcomes at 2 years post-lymph node dissection
- 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
Measured: Surgery to 2 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, open-label, two-arm, parallel-group Phase II clinical trial.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miles Mannas, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807293
- Sponsor's protocol ID
- H26-01861
- Acronym
- SALVAGE
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided