Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
MALE
NCT04271579

Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s)

Led by Martini-Klinik am UKE GmbH · Updated on 2026-01-12

397

Participants Needed

1

Research Sites

480 weeks

Total Duration

On this page

Sponsors

M

Martini-Klinik am UKE GmbH

Lead Sponsor

U

Universitätsklinikum Hamburg-Eppendorf

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s)

Who Can Participate

Age: 18Years - 75Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients in good general condition with life expectancy greater than 10 years
  • Hormone-sensitive prostate cancer recurrence after radical prostatectomy (patients after salvage prostatectomy may be included)
  • Unilateral detection of up to 3 PSMA PET positive lymph node metastases in the pelvis (up to origin of the inferior mesenteric artery)
  • PSA less than 4 ng/ml at the time of PSMA PET imaging
Not Eligible

You will not qualify if you...

  • 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
  • PSMA PET examination performed more than 4 months before salvage lymph node dissection
  • Hormone therapy within 6 months prior to study enrollment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Martini-Klinik am UKE GmbH

Hamburg, Germany, 20246

Actively Recruiting

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Research Team

T

Tobias Maurer, PD Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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