Prostate Cancer
Conditions
Keywords
Prostate Cancer, Lymph node dissection, Prostatectomy
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.
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.
Interventions
PROCEDUREPelvic lymph node dissection
Bilateral extended pelvic lymph node dissection
Sponsors
The Netherlands Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistent PSA rate | 6 months after surgery | Persistent PSA is defined as a PSA value ≥ 0.1 ng/ml after radical prostatectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metastasis-free survival | 3 years after surgery | This is defined as the time between radical prostatectomy to development of metastasis |
| Incidence of complications after surgery | 3 and 6 months after surgery | According to Clavien-Dindo classification |
| Incidence of salvage therapy after primary surgery | 3 years after surgery | I.e., androgen deprivation therapy, radiation therapy or salvage lymph node dissection |
| 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 |
| Biochemical recurrence (BCR) rate | 3 years after surgery | BCR is defined as a PSA value ≥ 0.2 ng/ml after radical prostatectomy |
| 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) |
| 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) |
| 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. |
| 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 |
Countries
Netherlands
Contacts
Primary ContactHenk G van der Poel, Prof
Backup ContactHilda A de Barros, MD
Outcome results
None listed