A Phase 2 interventional study of PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection and Salvage pelvic lymph node dissection in Prostate Cancer and Oligometastatic, sponsored by University of British Columbia. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by University of British Columbia · Phase 2, Interventional, and Treatment
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 62 is close to the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Salvage radioguided pelvic lymph node dissection
Other: Salvage pelvic lymph node dissection
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
Participants in the intervention arm will receive PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection.
Salvage standard lymph node dissection
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-op
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-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%
Time frame: 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: 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-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
Time frame: Surgery to 2 years post-operative
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-operative
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-operative
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-operative
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2030, 49 months later.
Of 610 non-industry phase 2 interventional studies under Prostatic Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 86. This study's planned 49 months is below that.
Counting every sponsor, half of 724 studies reached it within 53 months; a quarter within 34 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of British Columbia →