Oligometastatic, Prostate Cancer
Conditions
Keywords
prostate cancer, PSMA, radioguided surgery, olgiometastasis, Recurrent
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.
Interventions
PROCEDUREPSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection
Participants in the intervention arm will receive PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection.
OTHERSalvage pelvic lymph node dissection
Salvage standard lymph node dissection
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, randomized, open-label, two-arm, parallel-group Phase II clinical trial.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic metastatic yield | 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
| Measure | Time frame | Description |
|---|---|---|
| PSMA PET/CT and pathologic node concordance | 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. |
| Biochemical response at Week 6 | 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% |
| Patient-reported quality-of-life outcomes | 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: 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) |
| Long-term biochemical and clinical outcomes at 2 years post-lymph node dissection | 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 |
Contacts
CONTACTMiles P Mannas, MD, MSc, FRCSC
Outcome results
None listed