Status:
UNKNOWN
Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s)
Lead Sponsor:
Martini-Klinik am UKE GmbH
Collaborating Sponsors:
University Hospital Hamburg, Institute of Tumor Biology
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
NA
Brief Summary
Significant advances in molecular nuclear medicine imaging in prostate cancer have been achieved in recent years. In particular, the introduction of prostate-specific membrane antigen (PSMA) -based tr...
Detailed Description
In this prospective randomized study, patients with early biochemical recurrence after radical prostatectomy and with PSMA-PET positive unilateral pelvic metastatic lesions are assessed as to whether ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT04271579
Start Date
October 15 2019
End Date
December 31 2025
Last Update
April 12 2023
Active Locations (1)
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1
Martini-Klinik am UKE GmbH
Hamburg, Germany, 20246