Sclerotherapy of Internal Spermatic Veins in Patients With Varicocele and Localized Prostate Cancer
Patients with varicocele in whon early prostate cancer will be found will undergo venographic embolization of both spermatic veins. The study hypothesis is that this procedure will induce a gradual regression of the prostate volume that may decrease prostate cancer cells. Close follow-up will ensure that necessary therapy will be provided if needed according to clinical criteria. Results in terms of prostate size PSA level and tumor size will be recorded.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Selective Retrograde Venography and Sclerotherapy of Internal Spermatic Veins and Associated Venous Bypasses and Retro-Peritoneal Collateral in Patients With Bilateral Varicocele and Localized Prostate Cancer|
- Safety performance of the procedure. The change in tumor size and prostate cancer cells as evaluated by trans-rectal ultrasound and prostate biopsy [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- The change in size of the prostate as evaluated by ultrasound Change in PSA value. Reduction of above 20% in nocturia [ Time Frame: one year ]
|Study Start Date:||November 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Procedure: venographic occlusion of spermatic veins
Through the femoral vein a catheter is inserted into the spermatic veins in succession and the veins are occluded.
No Intervention: 2