Targeted treatment for early prostate cancer recurrence using advanced imaging
Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s): is One-sided Salvage Extended Lymph Node Dissection Enough
NA · Martini-Klinik am UKE GmbH · NCT04271579
This study is testing whether removing lymph nodes on one side or both sides helps men with early prostate cancer recurrence found through special imaging, and if it leads to better outcomes and fewer side effects.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 397 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Martini-Klinik am UKE GmbH (other) |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT04271579 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with hormone-sensitive prostate cancer recurrence after radical prostatectomy, in good health, and with localized PSMA PET positive lymph node metastases.
Not a fit: Patients with contraindications for surgery, suspected local recurrence, or extrapelvic metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients experiencing early prostate cancer recurrence.
How similar studies have performed: Other studies utilizing PSMA PET imaging for prostate cancer management have shown promising results, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, prostate cancer recurrence, salvage lymph node dissection