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

Launched by MARTINI-KLINIK AM UKE GMBH · Feb 14, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how effective a surgical procedure called unilateral pelvic lymph node dissection is in treating prostate cancer that has returned after surgery. Traditionally, doctors would remove lymph nodes from both sides of the pelvis, even if only one side showed signs of cancer. This trial aims to find out if removing lymph nodes from just the affected side is enough, which could help avoid unnecessary surgery and reduce the risk of complications. The focus is on patients who have a specific type of prostate cancer recurrence that is hormone-sensitive, have a good overall health condition, and have low levels of a blood marker called PSA.

To be eligible for the study, participants should be men with a life expectancy of over 10 years, have been diagnosed with prostate cancer that has come back, and have up to three positive lymph nodes detected on a special scan called PSMA PET. They should also have a PSA level below 4 ng/ml at the time of the scan. If you join the trial, you can expect to undergo the surgery to remove the affected lymph nodes and be monitored for how well this approach works in controlling the cancer. This research could lead to more personalized treatment options and potentially improve the quality of life for men dealing with prostate cancer recurrence.

Gender

MALE

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