Extended Pelvic Lymph Node Dissection vs. No Pelvic Lymph Node Dissection During Radical Prostatectomy in High-Grade Prostate Cancer Patients DISSECTION (2.0).

University Hospital Basel

Status

Not yet enrolling

Conditions

Prostate Cancer Surgery

Prostate Cancers

Treatments

Procedure: Extended Pelvic Lymph Node Dissection

Study type

Interventional

Funder types

Other

Identifiers

NCT06776172

KFS-5775-02-2023 (Other Grant/Funding Number)

2024-02381 bb24Rentsch2;

Details and patient eligibility

About

The aim of the DISSECTION 2.0 study is to determine whether extended pelvic lymph node dissection (ePLND) provides a therapeutic benefit for high-risk prostate cancer patients by improving cancer staging and potentially removing micrometastatic disease, ultimately improving their outcomes.

Full description

Prostate cancer is the second most common cancer in men globally and a major cause of cancer deaths in Europe. For men with localized prostate cancer (PCa) and a life expectancy of over 10 years, radical prostatectomy (RP) is the standard treatment. It improves survival compared to conservative management. However, there is debate about de benefit of pelvic lymph node dissection (PLND), the removal of lymph nodes in the pelvis, during RP. While PLND can be omitted in low risk PCa patients, extended PLND (ePLND) is recommended in PCa patients at high-risk for recurrence in order to improve nodal staging The DISSECTION 2.0 study aims to investigate whether extended PLND (ePLND) provides additional benefits for men with high-risk PCa. The hypothesis is that ePLND might help by removing undetectable cancer cells (micrometastases) in the lymph nodes or by better staging the disease for treatment planning. While imaging techniques like PSMA-PET are good at detecting cancer spread, they still miss approximately 60% of cancer-bearing lymph nodes, leaving room for ePLND to potentially improve outcomes.

ePLND involves removing more lymph nodes than standard PLND, leading to better detection of cancer spread. However, it also increases surgery time and complications slightly, though serious complications are rare.

Enrollment

400 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years and life expectancy >15 years
Any biopsy-proven WHO/ISUP grade groups III-V PCa
High-risk prostate cancer defined as:
- Any biopsy-proven WHO/ISUP grade group III-V PCa or
- ISUP grade group II and PSA > 20 ng/ml
PSMA-PET: negative staging for regional and distant metastasis
multidisciplinary tumorboard recommendation for radical prostatectomy
WHO performance status 0-1
Adequate condition (ASA ≤ III) for general anesthesia and RP

Exclusion criteria

ISUP grade group I PCa and cT1 or cT2 (MRI)
cT4 (MRI) PCa
PSMA-PET: positive staging for local and distant metastasis
Any prior neoadjuvant, local or systemic treatment for PCa
Previous PLND or pelvic radiotherapy
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.
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, which affect patient compliance or place the patient at
high risk from treatment-related complications.
Vulnerable men (participants incapable of judgment or participants under tutelage) will not be included in the study.