The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy

Sponsor
The Netherlands Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05109910
Collaborator
(none)
284
Enrollment
1
Location
2
Arms
71.5
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An extended pelvic lymph node dissection (ePLND) is the most accurate staging method to assess the presence of lymph node metastases in prostate cancer (PCa) patients. The therapeutic value, however remains unclear. Prospective randomized trials to address this void are lacking. Since in intermediate and a proportion of high risk PCa the risk of nodal metastases is generally below 25%, the vast majority of men undergo a procedure that has no oncological benefit, but is not without toxicity.

Therefore, the investigators aim to compare the oncologic outcomes of intermediate- and high-risk PCa patients with an estimated risk of lymph node invasion of 5-20% undergoing a radical prostatectomy (RP) with or without an ePLND.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Pelvic lymph node dissection
N/A

Detailed Description

The role of an extended pelvic lymph node dissection (ePLND) in patients undergoing radical prostatectomy (RP) remains controversial. An ePLND is the most accurate staging method to assess the presence of lymph node metastases. Lymph node involvement is associated with a significantly worse prognosis and may require immediate or delayed adjuvant therapy. However, an ePLND is associated with an increased risk of complications such as lymphoceles, thromboses and lymphedema, and prolongs surgery and patient recovery. Thus, the diagnostic advantage of PLND should be weighed against the potential morbidity.

The therapeutic value of an ePLND remains especially unclear in PCa patients with an estimated risk of lymph node invasion (LNI) ≤ 20%, where only a minority of patients will have nodes harbouring metastases. Prospective trials to address this issue are still lacking.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
284 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
Anticipated Study Start Date :
Nov 17, 2021
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2027

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Radical prostatectomy with an extended pelvic lymph node dissection

According to the standard of care, patients in this arm will receive a radical prostatectomy with a standard bilateral ePLND. This includes the removal of lymph nodes within the obturator fossa and bilateral to the external iliac artery, internal iliac artery and common iliac artery up to the ureteral-vessel crossing.

Procedure: Pelvic lymph node dissection
Bilateral extended pelvic lymph node dissection

No Intervention: Radical prostatectomy without an extended pelvic lymph node dissection

Patients in this arm will undergo a radical prostatectomy without a bilateral extended pelvic lymph node dissection. In case of intraoperatively found suspicious lymph nodes, a lymphadenectomy is performed. According to the intention to treat principle, patients with intraoperatively removed lymph nodes remain included in the study.

Outcome Measures

Primary Outcome Measures

  1. Persistent PSA rate [6 months after surgery]

    Persistent PSA is defined as a PSA value ≥ 0.1 ng/ml after radical prostatectomy

Secondary Outcome Measures

  1. Biochemical recurrence (BCR) rate [3 years after surgery]

    BCR is defined as a PSA value ≥ 0.2 ng/ml after radical prostatectomy

  2. Metastasis-free survival [3 years after surgery]

    This is defined as the time between radical prostatectomy to development of metastasis

  3. Incidence of complications after surgery [3 and 6 months after surgery]

    According to Clavien-Dindo classification

  4. Incidence of salvage therapy after primary surgery [3 years after surgery]

    I.e., androgen deprivation therapy, radiation therapy or salvage lymph node dissection

  5. Global Quality of life after surgery [6, 12, 24 and 36 months after surgery]

    Quality of life (QoL) will be assessed with the EORTC Core Quality of Life questionnaire's (QLQ-C30) global QoL scale ranging from 0 to 100, higher scores indicate better QoL

  6. Health-related quality of life of patients with prostate cancer [6, 12, 24 and 36 months after surgery]

    Health-related quality of life in prostate cancer patients will be assessed with the EORTC Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25) with a scale ranging from 0 to 100, higher scores indicate either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of (sexual) activity or functioning

  7. Urinary continence after surgery [6, 12, 24 and 36 months after surgery]

    Urinary continence will be assessed with the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) questionnaire, ranging from 0 (best) to 21 (worst)

  8. Urinary voiding symptoms [6, 12, 24 and 36 months after surgery]

    Urinary voiding symptoms will be assessed with the International Prostatic Symptoms Score (IPSS), ranging from 0 (best) to 35 (worst)

  9. Potency after surgery [6, 12, 24 and 36 months after surgery]

    Potency will be assessed with the International Index of Erectile Function (IIEF) questionnaire. The IIEF classifies the severity of erectile dysfunction into five categories stratified by score: No erectile dysfunction. Score: 26-30 Mild erectile dysfunction. Score: 22-25 Mild to moderate erectile dysfunction. Score: 17-21 Moderate erectile dysfunction. Score: 11-16 Severe erectile dysfunction. Score: 6-10.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Male, aged ≥ 18 years

  • Prostate cancer patients with a Briganti calculated risk of LN metastases of 5-20% without evidence of metastases on Prostate-Specific Membrane Antigen (PSMA) PET/CT requiring an ePLND in the standard treatment

  • Scheduled for a (robot-assisted) laparoscopic radical prostatectomy

  • Written informed consent

Exclusion Criteria:
  • American Society of Anaesthesiology (ASA) classification > 3

  • Patients with a contradiction for a lymphadenectomy

  • Neoadjuvant hormone deprivation therapy

  • Absence or withdrawal of an informed consent

  • Evidence of metastases on pre-operative PSMA PET/CT

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1NKI-AVLAmsterdamNetherlands1066 CX

Sponsors and Collaborators

  • The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Henk G van der Poel, Prof, The Netherlands Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT05109910
Other Study ID Numbers:
  • M20PRD
First Posted:
Nov 5, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Netherlands Cancer Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021