search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
venographic occlusion of spermatic veins
Sponsored by
Maaynei Hayesha Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, venography, male patients, Localized microscopic prostate cancer up to Gleason 6 (3+3), PSA level <14, presence of varicocele

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maaynei Hayesha Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Watch-full follow-up

Outcomes

Primary Outcome Measures

Safety performance of the procedure. The change in tumor size and prostate cancer cells as evaluated by trans-rectal ultrasound and prostate biopsy

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2008
Last Updated
March 14, 2008
Sponsor
Maaynei Hayesha Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00637208
Brief Title
Sclerotherapy of Internal Spermatic Veins in Patients With Varicocele and Localized Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maaynei Hayesha Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, venography, male patients, Localized microscopic prostate cancer up to Gleason 6 (3+3), PSA level <14, presence of varicocele

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Arm Description
Watch-full follow-up
Intervention Type
Procedure
Intervention Name(s)
venographic occlusion of spermatic veins
Intervention Description
Through the femoral vein a catheter is inserted into the spermatic veins in succession and the veins are occluded.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Maaynei Hayesha Medical Center
City
Bnei Brak
ZIP/Postal Code
51544
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs