Prostate Cancer Recurrent
Conditions
Brief summary
Despite continuous technical improvements in urologic surgery, up to 40% of prostate cancer patients will develop biochemical recurrence after radical prostatectomy (RP), potentially because of micro metastasis at the time of the primary surgery. With improved radiological modalities and nuclear medicine tracers like 68Ga-PSMA PET/CT, which allow the localization of the site of recurrence, there is increasing interest in metastasis directed therapies, such as salvage lymph node dissection. The pelvic extended salvage lymph node dissection (sLND) is a promising option for treating prostate cancer patients with local recurrence after radical prostatectomy with curative intent. Several retrospective series has been published to determine the local value of sLND. Despite the first data seem to be feasible and promising, to date no prospective evaluation has been made. Thus sLND is still experimental according to the guidelines and is considered as an off label therapy. This prospective single center phase I/II study was conducted to investigate the safety and early efficacy of salvage lymph node dissection in prostate cancer patients with local pelvic recurrence after radical prostatectomy (RP) with curative intention.
Interventions
PROCEDURESalvage lymph node dissection
Open pelvic surgery to dissect pelvic lymph nodes. The landmarks for dissection are: 1. Inferior mesenteric artery 2. Ilioinguinal nerve 3. Inguinal ligament 4. Dorsal pelvic floor 5. Urinary bladder
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Prostate cancer patients with lymph node metastasis in pelvic imaging * Status post radical prostatectomy with curative intent * Ability for informed consent * No sign for bone or visceral metastasis * Male \> 18 years * ECOG performance status 0 or 1
Exclusion criteria
* Male \< 18 years * No ability for informed consent * Sign for bone or visceral metastasis * Deep venous thrombosis or pulmonary embolism within the last 6 months before study screening * ECOG performance status 2 or more
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of periperative complications within 90 days after surgery | 90 days |
| The Prostate specific antigen value after 6 weeks. | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in Prostate Specific Antigen doubling time | 2 years |
| Time until development of castration resistance | 2 years |
| Time until development of distant metastasis | 2 years |
Countries
Austria
Outcome results
None listed