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Prostate CancerPhase 3NCT03921996

Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer

A Phase 3 study testing Radical prostatectomy (RP) followed by ePLND and Radical prostatectomy (RP) only in people with Prostate Cancer, run by Swiss Cancer Institute at 11 sites in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

For patients with intermediate-risk prostate cancer plus a predicted risk of >5% for positive lymph nodes and with high-risk prostate cancer, international guidelines recommend ePLND along with the RP. Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Radical prostatectomy (RP) followed by ePLND and Radical prostatectomy (RP) only
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
11 sitesSwitzerland
Study dates
27 Aug 2019to 11 Nov 2021
Phase
Phase 3
Are there results?
None posted in the registry

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 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures.
  • Histologically proven localized adenocarcinoma of the prostate.
  • High-risk prostate cancer or intermediate-risk prostate cancer defined by D'Amico classification system, with an estimated risk of >5% of lymph node metastasis.
  • Patients with a prior malignancy and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence.
  • Age ≥ 18 years and ≤ 80 years.
  • WHO performance status 0-1.
  • Adequate condition (ASA ≤ III) for general anesthesia and radical prostatectomy surgery.
  • Baseline Quality of Life (QoL) questionnaires have been completed.

Who cannot join

  • Any pre-operative evidence for T4 disease.
  • Metastatic prostate cancer according to staging or evidence of lymph node metastasis by imaging, defined as any pelvic lymph node >9 mm in the short axis or positive lymph nodes detected by imaging techniques with sensitivities similar or better than PSMA-PET or Choline-PET prior to surgery.
  • PSA ≥ 50 ng/ml.
  • Any prior neo-adjuvant, local or systemic treatment for prostate cancer (alpha reductase inhibitors for treatment of benign hyperplasia are allowed)
  • Previous pelvic lymph node dissection.
  • Any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment.
  • Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Switzerland11 sites

  • Kantonsspital Aarau AG

    Aarau, 5001

  • Universitätsspital Basel

    Basel, 4031

  • Inselspital, Bern

    Bern, 3010

  • Kantonsspital Graubuenden

    Chur, 7000

  • Hôpitaux Universitaires Genève

    Geneva, 1211

  • Kantonsspital Baselland

    Liestal, 4410

  • Luzerner Kantonsspital

    Lucerne, 6000

  • Spital Thurgau AG (Frauenfeld and Münsterlingen)

    Münsterlingen, 8596

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • Stadtspital Triemli

    Zurich, 8063

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer: An International, Multicenter, Randomized Phase III Trial

For patients with intermediate-risk prostate cancer plus a predicted risk of >5% for positive lymph nodes and with high-risk prostate cancer, international guidelines recommend ePLND along with the RP. Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. We hypothesize that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.

Read the detailed description

Radical prostatectomy (RP) is the surgical standard treatment for men with localized prostate cancer (PCa) and a life expectancy of > 10 years. RP is a treatment option for localized PCa that shows benefit in prostate cancer-specific survival (PCSS) and overall survival compared to conservative management. According to the guideline recommendations of the European Association of Urology (EAU), RP should be accompanied by extended pelvic lymph node dissection (ePLND) in patients with intermediate-risk PCa (D'Amico classification) and > 5% nomogram (Briganti) predicted risk of positive lymph nodes and in all high-risk PCa cases.

Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. The primary goal of this trial is to provide high-level evidence regarding the therapeutic benefit of ePLND in intermediate- and high-risk PCa patients without clinical evidence of nodal involvement. It is hypothesized that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.

Conditions
Prostate Cancer
Being tested
Radical prostatectomy (RP) followed by ePLND, Radical prostatectomy (RP) only
Keywords
Extended pelvic lymph node dissection, Pelvic lymph node dissection, ePLND, Prostate Cancer, intermediate prostate cancer, High-risk prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radical prostatectomy (RP) followed by ePLNDProcedure or surgery

    ePLND is performed either before or after radical prostatectomy and includes the removal of all nodal and fibro-fatty tissue

  • Radical prostatectomy (RP) onlyProcedure or surgery

    Radical prostatectomy

Study groups in NCT03921996
Study groupRoleWhat they receive
arm A: ePLNDExperimentalRadical prostatectomy with extended pelvic lymph node dissection
Receives: Procedure: Radical prostatectomy (RP) followed by ePLND
arm B: no PLNDActive comparatorRadical prostatectomy only
Receives: Procedure: Radical prostatectomy (RP) only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to biochemical recurrence (BCR)

    The primary endpoint of this trial is time to BCR, defined as time from randomization to biochemical recurrence, defined as serum PSA level ≥ 0.2 ng/ml, with a second confirmatory serum PSA level ≥ 0.2 ng/ml. Patients not experiencing an event will be censored at the date of the last available assessment or at the start of adjuvant or salvage treatment, if any.

    Measured: From the date of randomization until the date of biochemical recurrence, assessed up to 15 years after surgery

Secondary outcomes (9)

  1. Prostate-specific antigen (PSA) persistence

    PSA persistence is defined as failure to reach a PSA value of <0.1 ng/ml within 12 weeks (+ 2 weeks) postoperatively.

    Patients with no assessments within the first 12 weeks (+ 2 weeks) after surgery will be counted as failures for this endpoint

    Measured: From the date of surgery to 14 weeks after surgery

  2. Time to initiation of adjuvant or salvage therapies

    Time to initiation of adjuvant or salvage therapies will be calculated as the time from randomization to the start of any type of adjuvant or salvage therapy. Patients not starting adjuvant or salvage therapies are censored at the last date they were known to be alive.

    Measured: From the date of randomization until the date of start of any type of adjuvant or salvage therapy, assessed up to 15 years after surgery

  3. Time to loco-regional recurrence

    Time to loco-regional recurrence will be calculated from randomization until local (prostate bed) or regional (extent of ePLND template) recurrence, whichever occurs first. Patients not experiencing an event will be censored at the date of the last available assessment or at the start of adjuvant or salvage therapy, if any.

    Measured: From the date of randomization until the date of local or regional recurrence, assessed up to 15 years after surgery

  4. Time to distant metastasis

    Time to distant metastasis will be calculated from randomization until first occurrence of distant metastasis. Patients not experiencing an event will be censored at the date of the last available assessment.

    Measured: From the date of randomization until the date of first occurrence of distant metastasis, assessed up to 15 years after surgery

  5. Prostate cancer-specific survival (PCSS)

    PCSS will be calculated as the time from randomization to the date of death due to prostate cancer. Patients who died due to other reasons will be censored at the time of death. All other patients will be censored at the last date they were known to be alive.

    Causes of death may require critical review by the coordinating investigator and the medical advisor. Particular attention will be paid to men who have been reported as having died from prostate cancer without previously reported progression or recurrence and men who were reported as having died from non-prostate cancer causes after developing biochemical or clinical progression.

    Measured: From the date of randomization until the date of death due to prostate cancer, assessed up to 15 years after surgery

  6. Overall survival (OS)

    OS will be calculated from randomization until death from any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.

    Measured: From the date of randomization until the date of death, assessed up to 15 years after surgery

  7. Intraoperative complications

    Intraoperative complications will be assessed using the CLASSIC system.

    Measured: During surgery

  8. Postoperative complications

    Postoperative complications will be assessed using the Clavien-Dindo classification.

    Measured: From the date of surgery to 14 weeks after surgery

  9. Adverse events (AE)

    AEs will be assessed according to NCI CTCAE v5.0.

    Measured: From the date of registration to 15 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2019
  2. Study start27 Aug 2019
  3. Primary completion11 Nov 2021
  4. Study completion11 Nov 2021

Why it stopped: Due to lack of funding.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
SAKK 09/18 is an international, multicenter, randomized, phase III surgical intervention trial
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03921996
Sponsor's protocol ID
SAKK 09/18
Status last verified
Mar 2023
First submitted
18 Apr 2019
Last updated
9 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radical prostatectomy (RP) followed by ePLND and Radical prostatectomy (RP) only in people with Prostate Cancer, run by Swiss Cancer Institute at 11 sites in Switzerland.

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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Switzerland. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to lack of funding.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to biochemical recurrence (BCR) (time frame: From the date of randomization until the date of biochemical recurrence, assessed up to 15 years after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03921996.

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 9 Mar 2023.

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