Prostate Cancer Clinical Trial
— PSMA-SELECTOfficial title:
Multi-institutional Evaluation of the Cost-effectiveness of PSMA-PET/CT for the Detection of Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients
To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET/CT) as a selection tool for performing extended lymph node dissection (ePLND) for prostate cancer (PCa) in the primary staging setting results in fewer ePLND procedures and therefore lower overall healthcare costs, lower patient burden in terms of intervention-related complications and morbidity, with comparable disease prognosis, compared to the current European Guideline-recommended standard practice which includes performing ePLND in PCa patients who are candidates for active treatment with a nomogram-calculated lymph node involvement (LNI) risk >5%.
Status | Recruiting |
Enrollment | 706 |
Est. completion date | August 31, 2026 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Biopsy proven adenocarcinoma of the prostate - Indication for ePLND combined with robot assisted radical prostatectomy (RARP) (MSKCC nomogram >5%, if not applicable when only MRI targeted biopsies are positive, the Briganti nomogram will be used) - Suitable for robot-assisted ePLND and RARP - Mentally competent and understanding of benefits and potential burden of the study - Written informed consent - No known allergies for PSMA tracer. Exclusion Criteria: - History of prior diagnosed or treated PCa - Known concomitant malignancies (except Basal Cell Carcinoma of the skin) - Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RARP - PSMA non-avid PCa (local tumor activity) - Presence of distant metastasis (M1) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Canisius Wilhelmina Ziekenhuis | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Canisius-Wilhelmina Hospital | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in biochemical recurrence rate between groups. | Biochemical recurrence (BCR) is defined as the occurrence of measurable (>0.2 ng/ml) prostate specific antigen (PSA), during routinely follow-up up to five years after surgery, determined at two different occasions with at least one week between them.The BCR-rate between the control group and intervention groups will be compared. | 2 years | |
Secondary | Total number of ePLNDs and PSMA PET/CTs performed and their intervention-related healthcare costs | Total number of ePLNDs and PSMA PET/CTs performed and their intervention-related healthcare costs such as consumption of operation room (OR) time, costs of complication-related interventions and associated (prolonged) hospital stay. | up to 5 years post-surgery | |
Secondary | Incidence and types of surgical complications after RARP and ePLND | Surgical complications are graded according to the Clavien-Dindo Classification, defined as:
Grade 1 = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade 3 = Requiring surgical, endoscopic or radiological intervention, not under (Grade 3a) or under general anesthesia (Grade 3b). Grade 4 = Life-threatening complication with single organ (Grade 4a) or Multiorgan dysfunction (Grade 4b). Grade 5 = Death of a patient. |
up to 1 year post-surgery | |
Secondary | Total nodes resected on ePLND and number of positive and negative nodes within and outside of the standard ePLND template | Total nodes resected on ePLND and number of positive and negative nodes within and outside of the standard ePLND template as described by the EAU guidelines. | up to 5 years post-surgery | |
Secondary | Occurrence of pelvic lymph node metastasis and distant metastasis (visceral, bone, distant lymph nodes, pelvic lymph nodes) on PSMA-PET/CT during follow-up | Time to appearance of pelvic lymph node metastasis (N1) and distant metastasis (M1) using PSMA PET/CT | up to 5 years post-surgery | |
Secondary | Initiation of salvage therapy | The time from surgery to the start of salvage therapy (salvage ePLND, salvage radiation treatment, systemic treatment [androgen deprivation therapy (ADT) and eventual additional chemotherapy]). | up to 5 years post-surgery | |
Secondary | Metastasis-free survival | The time from surgery to the time of the scan that showed first evidence of radiographically detected bone or soft tissue distant metastasis. | up to 5 years post-surgery | |
Secondary | Hormone-therapy free survival | The time from surgery to the start of hormone therapy (ADT) | up to 5 years post-surgery | |
Secondary | Diagnostic accuracy measures of PSMA PET/CT | Diagnostic accuracy measures including per-patient and per-template sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of PSMA PET/CT for the detection of lymph node metastasis at baseline and, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post-surgery. | up to 5 years post-surgery | |
Secondary | (Changes) in the EPIC-26 sexual functioning domain score between groups | Expanded Prostate Cancer Index Composite (EPIC)-26 will be used to measure sexual functioning. EPIC-26 contains five symptom domains (urinary incontinence, urinary irritative/obstructive, sexual, bowel, hormonal), scored from 0 (worst) to 100 (best). Questionnaires will be send out at baseline (diagnosis) and 12, 24, 36, 48 and 60 months following surgery. | up to 5 years post-surgery | |
Secondary | (Changes in) quality-adjusted life-years (EQ-5D-5L) in patients in the control group vs. intervention group | The EuroQol (EQ)-5 Dimension (D)-5 Level (L) is a health-related quality of life questionnaire which can be used to derive utilities from patients. The EQ-5D-5L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety. Each domain has 5 response levels: (1) no problems, (2) slight problems (3) moderate problems (4) severe problems and (5) unable to/extreme problems.
Questionnaires will be administered at baseline, 12, 24, 36, 48 and 60 months following diagnosis. |
up to 5 years post-surgery | |
Secondary | Total health care related costs (iMTA MCQ) in patients in the control group vs. intervention group | The institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (MCQ) measures all relevant health care related costs. The iMCQ includes questions related to frequently occurring contacts with health care providers. Questionnaires will be send out at baseline and 3, 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post-surgery. | up to 5 years post-surgery | |
Secondary | Total loss of productivity and presenteeism (iMTA PCQ) in patients in the control group vs. intervention group | The institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (PCQ) measures loss of productivity due to illness or recovery in patients below the age of 65 years based on patient reported absences from paid (or unpaid) labor. Questionnaires will be send out to each individual patient at baseline and, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post-surgery. | up to 5 years post-surgery |
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