Sclerotherapy of Internal Spermatic Veins in Patients With Varicocele and Localized Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637208
• Other study ID #: RVS-002-IL
• Secondary ID: MHMC grant
• Status: Completed
• Phase: N/A
• First received: March 9, 2008
• Last updated: March 14, 2008
• Start date: November 2007
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: Maaynei Hayesha Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Males age 45-75

• Prostate cancer

• Presence of varicocele

• No contraindication for venography

Exclusion Criteria:

• Diseases or medications which prevent interventional vascular procedures

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Varicocele

Intervention

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.

Locations

Country	Name	City	State
Israel	Maaynei Hayesha Medical Center	Bnei Brak

Sponsors (1)

Lead Sponsor	Collaborator
Maaynei Hayesha Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety performance of the procedure. The change in tumor size and prostate cancer cells as evaluated by trans-rectal ultrasound and prostate biopsy		one year	Yes
Secondary	The change in size of the prostate as evaluated by ultrasound Change in PSA value. Reduction of above 20% in nocturia		one year