Prostate CancerPrePSMANCT06398613
Preoperative PSMA PET/CT As Triage for EPLND in Patients Scheduled for RALP (PrePSMA)
A study testing extended pelvic lymph node dissection (ePLND) in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Extended pelvic lymph node dissection (ePLND) is considered the gold standard for nodal staging in men with prostate cancer (PCa). The aim of this project is to determine if preoperative prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomograpy (CT) can safely replace ePLND as a… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- extended pelvic lymph node dissection (ePLND)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNorway
- Study dates
- 26 Apr 2024to 31 Dec 2029
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Biopsy proven diagnosed adenocarcinoma of the prostate
- Indication for ePLND combined with RALP:
- High-risk group (EAU) and including MRI findings indicating extra prostatic extension (Likert scale ≥4)
- -ISUP GG 3 with ≥1 of the following unfavourable risk factors
- cT2b-c,
- ≥50% percentage of positive biopsy cores,
Show all 11Show fewer
- PSA 10-20
- cN1 selected to surgery
- Written informed consent
- No known allergies for PSMA tracer
- 18 years and older
Who cannot join
- History of previously actively treated PCa
- Previous malignancies (except basal cell carcinoma of the skin) that has not been recurrence-free past ≥5 years
- Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RALP
- Presence of distant metastasis (cM1) on MRI imaging
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preoperative PSMA PET/CT As Triage for Extended Pelvic Lymph Node Dissection (ePLND) in Patients Scheduled for Robot-Assisted Laparoscopic Radical Prostatectomy (RALP)
Extended pelvic lymph node dissection (ePLND) is considered the gold standard for nodal staging in men with prostate cancer (PCa). The aim of this project is to determine if preoperative prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomograpy (CT) can safely replace ePLND as a staging method in PCa patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP).
Read the detailed description
Due to the latest change in EAU guidelines in May 2024, all eligible patients will undergo PSMA PET/CT. Patients will then be randomized between RALP and ePLND (Arm A) and RALP +/- ePLND (arm B): If PSMA PET/CT detect suspicious pelvic nodes, the patient will undergo ePLND concomitant with RALP. If PSMA PET/CT is negative, only RALP will be performed .
Primary outcome measures:
Difference in biochemical recurrence (BCR) rate between arm A and arm B within 2 years after initiation of primary treatment (BCR ≥ 0.2 ng/ml).
Secondary outcome measures:
Difference between Arm A and Arm B for surgical complications, persistent PSA after RALP and initiation of salvage therapy
- Conditions
- Prostate Cancer
- Being tested
- extended pelvic lymph node dissection (ePLND)
- Keywords
- PSMA PET/CT, ePLND
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended pelvic lymph node dissection (ePLND)Diagnostic test
Prostate-Specific Membrane Antigen Emission Tomography/Computed Tomography (PSMA PET/CT) will done preoperatively in both arms of the study. In arm A all patients will undergo ePLND, in arm B only patients with positive PSMA PET/CT will undergo ePLND
| Study group | Role | What they receive |
|---|---|---|
| RALP + ePLND Arm A | No intervention | RALP + ePLND |
| RALP +/- ePLND Arm B | Experimental | I preoperative PSMA PET/CT is positive for pelvic nodal metastasis, ePLND concomitant with RALP will be performed. If PSMA PET/CT is negative, only RALP will be done. Receives: Diagnostic Test: extended pelvic lymph node dissection (ePLND) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between Arm A and Arm B in biochemical recurrence (BCR) rate between groups within 2 years after initiation of RALP
BCR is defined as PSA ≥ 0.2 ng/ml
Measured: 2 years after initiation of primary treatment
Secondary outcomes (3)
Difference between Arm A and Arm B in incidence and types of surgical complications
Clavien Dindo classification of complications will be used
Measured: 3 months follow up
Difference between Arm A and Arm B in persistent PSA after RALP
If the PSA value 6 weeks postoperatively is > 0.10 ng/ml the patient has persistent PSA
Measured: 2 months after RALP
Difference between Arm A and Arm B in initiation of salvage therapy
Salvage therapy is salvage radiation therapy, salvage surgery and ADT
Measured: 2 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start26 Apr 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus
- Responsible party
- Principal investigator, Viktor Berge, Oslo University Hospital
- Investigators
- Viktor Berge, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398613
- Sponsor's protocol ID
- REK 688379
- Acronym
- PrePSMA
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative PSMA PET/CT As Triage for Extended Pelvic Lymph Node Dissection (ePLND) in Patients Scheduled for Robot-Assisted Laparoscopic Radical Prostatectomy (RALP)
- ClinicalTrials.gov ID
- NCT06398613
- Acronym / sponsor ID
- PrePSMA / REK 688379
- Conditions
- Prostate Cancer
- Keywords
- PSMA PET/CT, ePLND
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 May 2024 (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.
Extended pelvic lymph node dissection (ePLND) is considered the gold standard for nodal staging in men with prostate cancer (PCa). The aim of this project is to determine if preoperative prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomograpy (CT) can safely replace ePLND as a staging method in PCa patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP).
Detailed description
Due to the latest change in EAU guidelines in May 2024, all eligible patients will undergo PSMA PET/CT. Patients will then be randomized between RALP and ePLND (Arm A) and RALP +/- ePLND (arm B): If PSMA PET/CT detect suspicious pelvic nodes, the patient will undergo ePLND concomitant with RALP. If PSMA PET/CT is negative, only RALP will be performed .
Primary outcome measures:
Difference in biochemical recurrence (BCR) rate between arm A and arm B within 2 years after initiation of primary treatment (BCR ≥ 0.2 ng/ml).
Secondary outcome measures:
Difference between Arm A and Arm B for surgical complications, persistent PSA after RALP and initiation of salvage therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RALP + ePLND Arm A | No intervention | –RALP + ePLND |
| RALP +/- ePLND Arm B | Experimental | Diagnostic Test: extended pelvic lymph node dissection (ePLND)I preoperative PSMA PET/CT is positive for pelvic nodal metastasis, ePLND concomitant with RALP will be performed. If PSMA PET/CT is negative, only RALP will be done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Biopsy proven diagnosed adenocarcinoma of the prostate
- Indication for ePLND combined with RALP:
- High-risk group (EAU) and including MRI findings indicating extra prostatic extension (Likert scale ≥4)
- -ISUP GG 3 with ≥1 of the following unfavourable risk factors
- cN1 selected to surgery
Key exclusion criteria (4 listed)
- History of previously actively treated PCa
- Previous malignancies (except basal cell carcinoma of the skin) that has not been recurrence-free past ≥5 years
- Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RALP
- Presence of distant metastasis (cM1) on MRI imaging
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 |
|---|---|---|
| extended pelvic lymph node dissection (ePLND)Prostate-Specific Membrane Antigen Emission Tomography/Computed Tomography (PSMA PET/CT) will done preoperatively in both arms of the study. In arm A all patients will undergo ePLND, in arm B only patients with positive PSMA PET/CT will undergo ePLND | Diagnostic test | RALP +/- ePLND Arm B |
Primary outcome
Difference between Arm A and Arm B in biochemical recurrence (BCR) rate between groups within 2 years after initiation of RALP
Time frame: 2 years after initiation of primary treatment
BCR is defined as PSA ≥ 0.2 ng/ml
3 secondary outcomes
Difference between Arm A and Arm B in incidence and types of surgical complications
Time frame: 3 months follow up
Difference between Arm A and Arm B in persistent PSA after RALP
Time frame: 2 months after RALP
Difference between Arm A and Arm B in initiation of salvage therapy
Time frame: 2 years follow up
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 31 Dec 2024.
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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.
Viktor Berge principal investigator
Oslo University 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 extended pelvic lymph node dissection (ePLND) in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
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 11 inclusion and 4 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 31 Dec 2024. 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 Norway. 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 Viktor Berge, PhD (+4791599615, vikber@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between Arm A and Arm B in biochemical recurrence (BCR) rate between groups within 2 years after initiation of RALP (time frame: 2 years after initiation of primary treatment). 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 31 Dec 2024.