Extended vs. No Pelvic Lymph Node Dissection During Radical Prostatectomy. DISSECTION 2.0.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years and life expectancy >15 years
Any biopsy-proven WHO/ISUP grade groups III-V PCa
Any biopsy-proven WHO/ISUP grade group III-V PCa or
ISUP grade group II and PSA > 20 ng/ml
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Extended Pelvic Lymph Node Dissection
Procedure/SurgeryExtended pelvic lymph node dissection during radical prostatectomy
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Radical prostatectomy with extended pelvic lymph node dissectionExperimental treatment 1 intervention
Group B: Radical prostatectomy without extended pelvic lymph node dissectionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Prostate specific antigen (PSA) persistence
defined as failure to reach a PSA value of \<0.1 ng/ml
Time frame
3 month (+/- 2 weeks) postoperatively2
Biochemical recurrence free survival (BCRFS)
time from randomization to biochemical recurrence, defined as serum PSA level ≥ 0.2 ng/ml
Time frame
within 24 months post surgerySecondary outcomes
1
PSA persistence (PSAP) above detection limit
cut-off ≥ 0.03 ng/ml
Time frame
postoperative to the end of the study at 10-15 years2
Initiation time of adjuvant or salvage therapies
Calculated from randomization to the start of any adjuvant or salvage therapy. Salvage radiotherapy (SRT) to the prostatic fossa only excluding lymphatics and without androgen deprivation therapy) will not count as an event for this endpoint if: * A PSMA-PET-computed tomography prior to SRT was negative for disease beyond the prostatic fossa, and * the SRT led to a PSA \<0.1 ng/ml (PSAP) or ≤ 0.2 ng/ml (biochemical recurrence-free survival, BCRFS), respectively.
Time frame
postoperative to the end of the study at 10-15 years3
Time to loco-regional recurrence
Calculated from randomization until the first local (prostate bed) or regional (within the extent of the ePLND template) recurrence.
Time frame
from randomization to end of study at 10-15 years4
Localization of progression
Prostate-specific membrane antigen positron emission tomography (PSMA-PET)
Time frame
from randomization to end of study at 10-15 yearsOther outcomes
1
Evaluation of risk prediction for nodal invasion
from prostate biopsy results
Time frame
postoperative to the end of the study at 10-15 years2
Evaluation of the potential value of unilateral ePLND
Time frame
postoperative to the end of the study at 10-15 yearsSponsors and contacts
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Source ClinicalTrials.gov