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

About This Trial

This study is for men whose prostate cancer has returned after surgery and has spread to only a few lymph nodes on one side of the pelvis.
Researchers are testing whether surgically removing lymph nodes from just the affected side works as well to control the disease as operating on both sides.
The goal is to delay the cancer's spread and put off long-term drug treatments while lowering the risk of surgical complications, like leg swelling and fluid buildup.
Before considering this trial, patients should know it requires a surgical procedure and is only open to individuals in good general health who have not received hormone therapy in the last six months.

More Information

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.

Who Can Enroll

Age Range: 18 - 75 years
Gender: Male
Who This Trial is For: This study is for men whose prostate cancer has returned after surgery and has spread to only a few lymph nodes on one side of the pelvis.

Study Details

Start Date: October 15, 2019
Lead Sponsor: Martini-Klinik am UKE GmbH

Full 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 months prior to salvage lymph node dissection
Hormone therapy within 6 months prior to study enrollment