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

• Sponsor: Maaynei Hayesha Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00637208
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Procedure: venographic occlusion of spermatic veins	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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 Watch-full follow-up

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. The change in size of the prostate as evaluated by ultrasound Change in PSA value. Reduction of above 20% in nocturia [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maaynei Hayesha Medical Center	Bnei Brak		Israel	51544

Sponsors and Collaborators

• Maaynei Hayesha Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00637208
• Other Study ID Numbers: RVS-002-IL; MHMC grant
• First Posted: Mar 17, 2008
• Last Update Posted: Mar 17, 2008
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: prostate cancer; venography; male patients; Localized microscopic prostate cancer up to Gleason 6 (3+3); PSA level <14; presence of varicocele
• Additional relevant MeSH terms: Prostatic Neoplasms; Varicocele

Study Results

No Results Posted as of Mar 17, 2008