Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s): is One-sided Salvage Extended Lymph Node Dissection Enough

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 tracers has significantly influenced diagnostic imaging of prostate. If cancer recurs after surgical removal of the prostate, targeted PSMA PET (positron emission tomography) can detect metastases even at very low PSA (prostate-specific Antigen) values. This increasingly allows individualized specific therapy of patients with prostate cancer recurrence. PSMA PET has now been included in national and international guidelines for the diagnosis of patients with biochemical recurrence of prostate cancer. Especially in patients in good general condition, with potentially longer life expectancy and early localized PSA recurrence, advances in molecular imaging are increasingly turning local therapy concepts into focus. Here both, radiotherapeutic (salvage radiotherapy of the lymphatic drainage) and surgical interventions (salvage lymph node dissection = removal of the pelvic lymph nodes) are offered on an individual basis. These regional therapies mainly aim to achieve a delay of further progression of the prostate cancer disease, and thus delay the initiation of palliative, sustained drug therapy. Previous standard or common practice at salvage lymph node dissection is the removal on both sides of the pelvic lymph nodes even if only one-sided suspicious lymph nodes are detected on imaging. Although the complications of salvage lymph node dissection are usually minor and manageable, they can still lead to impaired lymphatic drainage, leg edema, lymphocele formation or other surgical complications. The aim of the present study is to investigate whether a unilateral pelvic lymph node dissection on the side of conspicuous PSMA PET is sufficient and a dissection on the contralateral side can be dispensed without negatively impacting oncological outcomes and thereby sparing the patient the potential additional complications of a bilateral pelvic lymph node dissection.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Martini-Klinik am UKE GmbH
RECRUITING
Hamburg
Contact Information
Primary
Tobias Maurer, PD Dr.
t.maurer@uke.de
+49 (0) 40 7410 53115
Time Frame
Start Date: 2019-10-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 397
Treatments
Active_comparator: Unilateral lymphnode dissection
Salvage lymphnode dissection is performed on the PSMA PET positive side, according to template (obturator, iliac external, iliac internal, iliac commun) and possibly including other anatomical pelvic regions
Active_comparator: bilateral Lymphnode dissection
In addition, a salvage lymphnode dissection is performed on the opposite side with resection of the corresponding fields, which were taken on the PSMA-PET positive side
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital Hamburg, Institute of Tumor Biology
Leads: Martini-Klinik am UKE GmbH

This content was sourced from clinicaltrials.gov

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