Radioguided Salvage Pelvic Node Dissection in Oligometastatic Prostate Cancer - SALVAGE
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of British Columbia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Not meeting inclusion criteria
Trial design
Design model
Parallel
Treatments tested in this trial
PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection
Procedure/SurgeryParticipants in the intervention arm will receive PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection.
Salvage pelvic lymph node dissection
Other interventionSalvage standard lymph node dissection
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Salvage pelvic lymph node dissectionActive comparator 1 intervention
Group B: PSMA technetium assisted radioguided salvage lymph node dissectionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
2-4 weeks post-opSecondary outcomes
1
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.
Time frame
2-4 weeks post-op2
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%
Time frame
Surgery to 6 week post-op3
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: 1. Change from baseline in each EPIC-26 domain score at each follow-up timepoint. 2. Between-group differences in EPIC-26 domain scores over time. 3. 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)
Time frame
Date of surgery until 2 years post-operative4
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
Time frame
Surgery to 2 years post-operativeOther outcomes
1
Pattern of recurrence on PSMA-PET/CT at first biochemical recurrence/persistence
* 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
Time frame
Surgery until 2 years post-operative2
Disease burden at biochemical persistence:
-Number of PSMA-avid lesions per participant on PSMA-PET/CT, compared descriptively between treatment arms
Time frame
Surgery until 2 years post-operative3
PSMA-PET/CT detection rate at biochemical persistence:
-Proportion of participants with at least one PSMA-avid lesion identified on PSMA-PET/CT
Time frame
Surgery until 2 years post-operativeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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