Early Prostate cancer recurrence with PSMA PET positive unilateral pelvic lesion(s): is one-sided salvage extended lymph node dissection enough?
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00020130
- Lead Sponsor
- Martini-Klinik am UKE GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 397
• 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
• 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of complete biochemical response (cBR: PSA <0.2ng / ml) 24 months after salvage lymph node dissection without adjuvant prostate cancer specific therapy
- Secondary Outcome Measures
Name Time Method • 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<br>• Prostate cancer-specific therapy-free survival after salvage lymph node 3, 6, and 12 months after salvage lymph node dissection<br>