Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00637208
Recruitment Status : Completed
First Posted : March 17, 2008
Last Update Posted : March 17, 2008
Sponsor:
Information provided by:
Maaynei Hayesha Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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 : November 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 [ Time Frame: 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 [ Time Frame: one year ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637208


Locations
Layout table for location information
Israel
Maaynei Hayesha Medical Center
Bnei Brak, Israel, 51544
Sponsors and Collaborators
Maaynei Hayesha Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Dr Uriel Levinger, Maaynei Hayesha Medical Center
ClinicalTrials.gov Identifier: NCT00637208     History of Changes
Other Study ID Numbers: RVS-002-IL
MHMC grant
First Posted: March 17, 2008    Key Record Dates
Last Update Posted: March 17, 2008
Last Verified: March 2008
Keywords provided by Maaynei Hayesha Medical Center:
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:
Layout table for MeSH terms
Prostatic Neoplasms
Varicocele
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases
Vascular Diseases
Cardiovascular Diseases