An interventional study of PSMA-PET/CT and Nomogram in Prostate Cancer Metastatic, Prostate Cancer and Lymph Node Metastases, sponsored by Canisius-Wilhelmina Hospital. Recruiting at 1 site in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Canisius-Wilhelmina Hospital · Not applicable, Interventional, and Diagnostic
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%.
Background: Use of prostate-specific membrane antigen (PSMA) positron emission tomography (PET) - computer tomography (CT) has drastically improved the ability to detect and exclude presence of pelvic lymph node invasion (LNI) compared to conventional imaging. However, current standard of care still includes performing extended pelvic lymph node dissection (ePLND) in all patients with primary prostate cancer and a nomogram-based risk of LNI >5%. It is unclear if use of PSMA PET/CT as a triage test can safely reduce the number of ePLND and hence reduce the associated morbidity and costs, without negatively influencing disease prognosis.
Objective: To assess whether PSMA PET/CT can be safely used as a triage test for selecting primary prostate cancer patients for ePLND. We will additionally assess cost-effectiveness of the PSMA PET/ CT triage strategy.
Design, setting and Participants: THE PSMA-SELECT trial includes patients with biopsy-confirmed prostate cancer, without evidence of distant metastasis (M0) on PSMA PET/CT, opting for treatment with radical prostatectomy (RP), with a nomogram-calculated risk of LNI >5%. Patients will be randomized 1:1. In the intervention arm patients will only undergo ePLND in addition to robot-assisted radical prostatectomy (RARP) in case of suspected LNI on PSMA PET/CT (miN1), whereas ePLND will be omitted in those without PSMA positive lymph nodes (miN0). In the control arm, all patients will undergo ePLND in addition to RARP.
Outcome measurements and statistical analysis: The primary endpoint of this study is biochemical recurrence rate at two years post-surgery. Secondary outcome measures are number of ePLNDs indicated and performed, treatment-related adverse events, initiation of salvage treatment, metastasis-free survival, patient-reported outcome measures and individual and cumulative healthcare costs.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 706 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Canisius-Wilhelmina Hospital is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Node-negative PSMA PET/CT \[N0\] and M0: do not perform ePLND 2. Node-positive PSMA PET/CT \[N1\] and M0: perform ePLND
Device: PSMA-PET/CT
Nomogram-based indication for ePLND (conform current EAU guidelines)
Other: Nomogram
In the intervention arm patients will only undergo ePLND in addition to robot-assisted radical prostatectomy (RARP) in case of suspected LNI on PSMA PET/CT (miN1), whereas ePLND will be omitted in those without PSMA positive lymph nodes (miN0).
Current standard of care includes performing extended pelvic lymph node dissection (ePLND) in all patients with primary prostate cancer and a nomogram-based risk of LNI \>5%
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.
Time frame: 2 years
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.
Time frame: up to 5 years post-surgery
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.
Time frame: up to 1 year post-surgery
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.
Time frame: up to 5 years post-surgery
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
Time frame: up to 5 years post-surgery
Initiation of salvage therapy
The time from surgery to the start of salvage therapy (salvage ePLND, salvage radiation treatment, systemic treatment \[androgen deprivation therapy (ADT) and eventual additional chemotherapy\]).
Time frame: up to 5 years post-surgery
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.
Time frame: up to 5 years post-surgery
Hormone-therapy free survival
The time from surgery to the start of hormone therapy (ADT)
Time frame: up to 5 years post-surgery
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.
Time frame: up to 5 years post-surgery
(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.
Time frame: up to 5 years post-surgery
(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.
Time frame: up to 5 years post-surgery
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.
Time frame: up to 5 years post-surgery
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.
Time frame: up to 5 years post-surgery
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2021 (actual). Primary completion is estimated for Jul 2025, 48 months after the start.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 48 months is above that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
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Canisius-Wilhelmina Hospital