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Clinical Trials/DRKS00020130
DRKS00020130
Recruiting
N/A

Early Prostate cancer recurrence with PSMA PET positive unilateral pelvic lesion(s): is one-sided salvage extended lymph node dissection enough? - ProSTone Study

Martini-Klinik am UKE GmbH0 sites397 target enrollmentNovember 29, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
C61
Sponsor
Martini-Klinik am UKE GmbH
Enrollment
397
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 29, 2019
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
Male

Investigators

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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