Prostate Cancer MetastaticPSMA-SELECTNCT05000827
Dutch National Randomized Study: PSMA-PET/CT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients
A study testing PSMA-PET/CT and Nomogram in people with Prostate Cancer Metastatic and Prostate Cancer, run by Canisius-Wilhelmina Hospital at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic, Prostate Cancer, Lymph Node Metastases
- What is being tested?
- PSMA-PET/CT and Nomogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 706 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Jul 2021to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532 SZ
L Wever, 0681806668 ext. +316, l.wever@cwz.nl
About this study
Official 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%.
Read the detailed description
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.
- Being tested
- PSMA-PET/CT, Nomogram
- Medical subject headings
- Prostatic Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA-PET/CTDevice
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).
NomogramOther
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%
| Study group | Role | What they receive |
|---|---|---|
| PSMA PET/CT based indication for ePLND: | Experimental | 1. Node-negative PSMA PET/CT [N0] and M0: do not perform ePLND
2. Node-positive PSMA PET/CT [N1] and M0: perform ePLND Receives: Device: PSMA-PET/CT |
| Nomogram-based indication for ePLND (standard of care) | Active comparator | Nomogram-based indication for ePLND (conform current EAU guidelines) Receives: Other: Nomogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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]).
Measured: 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.
Measured: up to 5 years post-surgery
Hormone-therapy free survival
The time from surgery to the start of hormone therapy (ADT)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start28 Jul 2021
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention PSMA PET/CT based indication for ePLND: 1. Node-negative PSMA PET/CT \[N0\] and M0: do not perform ePLND 2. Node-positive PSMA PET/CT \[N1\] and M0: perform ePLND Comparator Nomogram-based indication for ePLND (conform current EAU guidelines)
- Masking
- None (open label)
- Enrolment
- 706 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canisius-Wilhelmina Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Jean-Paul A. van Basten, Principal investigator, Canisius-Wilhelmina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000827
- Sponsor's protocol ID
- NL76042.091.21
- Other IDs
- 2021-8189
- Acronym
- PSMA-SELECT
- Status last verified
- Feb 2025
- First submitted
- 28 Jul 2021
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05000827
- Acronym / sponsor ID
- PSMA-SELECT / NL76042.091.21
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 706 participants (estimated)
- Lead sponsor
- Canisius-Wilhelmina HospitalUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention PSMA PET/CT based indication for ePLND: 1. Node-negative PSMA PET/CT [N0] and M0: do not perform ePLND 2. Node-positive PSMA PET/CT [N1] and M0: perform ePLND Comparator Nomogram-based indication for ePLND (conform current EAU guidelines)
| Arm | Type | Receives |
|---|---|---|
| PSMA PET/CT based indication for ePLND: | Experimental | Device: PSMA-PET/CT1. Node-negative PSMA PET/CT [N0] and M0: do not perform ePLND 2. Node-positive PSMA PET/CT [N1] and M0: perform ePLND |
| Nomogram-based indication for ePLND (standard of care) | Active comparator | Other: NomogramNomogram-based indication for ePLND (conform current EAU guidelines) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA-PET/CTIn 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). | Device | PSMA PET/CT based indication for ePLND: |
| NomogramCurrent 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% | Other | Nomogram-based indication for ePLND (standard of care) |
Primary outcome
Difference in biochemical recurrence rate between groups.
Time frame: 2 years
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.
12 secondary outcomes
Total number of ePLNDs and PSMA PET/CTs performed and their intervention-related healthcare costs
Time frame: up to 5 years post-surgery
Incidence and types of surgical complications after RARP and ePLND
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
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 frame: up to 5 years post-surgery
Initiation of salvage therapy
Time frame: up to 5 years post-surgery
Metastasis-free survival
Time frame: up to 5 years post-surgery
Hormone-therapy free survival
Time frame: up to 5 years post-surgery
Diagnostic accuracy measures of PSMA PET/CT
Time frame: up to 5 years post-surgery
(Changes) in the EPIC-26 sexual functioning domain score between groups
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
Time frame: up to 5 years post-surgery
Total health care related costs (iMTA MCQ) in patients in the control group vs. intervention group
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
Time frame: up to 5 years post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Paul A. van Basten principal investigator
Canisius-Wilhelmina Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA-PET/CT and Nomogram in people with Prostate Cancer Metastatic and Prostate Cancer, run by Canisius-Wilhelmina Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lieke Wever (0681806668, l.wever@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in biochemical recurrence rate between groups. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.