C61
Conditions
Interventions
Group 1: Salvage lymphadenectomy is performed on the PSMA PET positive side, according to template (obturator, iliac external, iliac internal, iliac commun) and possibly including other anatomical pel
Sponsors
Martini-Klinik am UKE GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Patients in good general condition with life expectancy> 10 years • Hormone-sensitive prostate cancer recurrence after radical prostatectomy (patients with status post salvage prostatectomy may be included; salvage radiotherapy for prostate fossa and / or pelvic lymph drainage after radical prostatectomy is not an exclusion criterion) • Unilateral detection of = 3 PSMA PET positive lymph node metastases in the pelvis (up ot origin of the inferior mesenteric artery) • PSA at the time of PSMA PET imaging <4 ng / ml
Exclusion criteria
Exclusion criteria: • Contraindication for surgery or bilateral salvage lymph node dissection • Suspected prostate cancer recurrence in the prostate fossa (local recurrence) or extrapelvic metastasis on PSMA PET imaging • Date of PSMA PET examination > 4 months prior to salvage lymph node dissection • Hormone therapy within 6 months prior to study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete biochemical response (cBR: PSA <0.2ng / ml) 24 months after salvage lymph node dissection without adjuvant prostate cancer specific therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| • Rate of complete biochemical response (cBR: PSA <0.2ng / ml) 4 weeks, 3, 6 and 12 months after salvage lymph node dissection without adjuvant prostate cancer specific therapy • Prostate cancer-specific therapy-free survival after salvage lymph node 3, 6, and 12 months after salvage lymph node dissection | — |
Countries
Germany
Contacts
Public ContactAnke Renter
Martini-Klinik am UKE GmbH
Outcome results
None listed