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

This study has been completed.
Sponsor:
Information provided by:
Maaynei Hayesha Medical Center
ClinicalTrials.gov Identifier:
NCT00637208
First received: March 9, 2008
Last updated: March 14, 2008
Last verified: March 2008
  Purpose

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 Intervention
Prostate Cancer
Procedure: venographic occlusion of spermatic veins

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Maaynei Hayesha Medical Center:

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 [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: November 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637208

Locations
Israel
Maaynei Hayesha Medical Center
Bnei Brak, Israel, 51544
Sponsors and Collaborators
Maaynei Hayesha Medical Center
  More Information

No publications provided

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
Study First Received: March 9, 2008
Last Updated: March 14, 2008
Health Authority: Israel: Ministry of Health

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:
Prostatic Neoplasms
Varicocele
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014