Targeted treatment for early prostate cancer recurrence using advanced imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of unilateral versus bilateral salvage lymph node dissection in patients with early biochemical recurrence of prostate cancer, identified through PSMA PET imaging. It aims to determine if both approaches yield similar oncological outcomes, such as complete biochemical response and time to recurrence. Additionally, the study will assess the diagnostic accuracy of PSMA PET and the potential reduction in surgery-related side effects. Quality of life and psychological stress will also be evaluated using validated questionnaires.

Why it matters

Who can join: the full rules

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

Where it's running

• Martini-Klinik am UKE GmbH
  Hamburg, Germany Recruiting

Study contacts

• Study coordinator: Tobias Maurer, PD Dr.
• Email: t.maurer@uke.de
• Phone: +49 (0) 40 7410 53115

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.