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NCT Number: NCT05109910

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

NKI-AVL

Amsterdam, 1066 CX, Netherlands

Location status: Recruiting

Location contact

H.G van der Poel, Prof

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic lymph node dissection

Procedure

Bilateral extended pelvic lymph node dissection

Primary outcomes

  1. Persistent PSA rate

    Time frame: 6 months after surgery

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

Secondary outcomes

  1. Biochemical recurrence (BCR) rate

    Time frame: 3 years after surgery

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

  2. Metastasis-free survival

    Time frame: 3 years after surgery

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

  3. Incidence of complications after surgery

    Time frame: 3 and 6 months after surgery

    According to Clavien-Dindo classification

  4. Incidence of salvage therapy after primary surgery

    Time frame: 3 years after surgery

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

  5. Global Quality of life after surgery

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Henk G van der Poel, Prof

CONTACT

[email protected]

0205129111

Hilda A de Barros, MD

CONTACT

[email protected]

0205129111

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy

Important dates

Study start
2021
Primary completion
2024
Study completion
2027
First posted
Nov 5, 2021
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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