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OpenTrials
Completed

NCT Number: NCT00637208

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maaynei Hayesha Medical Center

Bnei Brak, 51544, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

venographic occlusion of spermatic veins

Procedure

Through the femoral vein a catheter is inserted into the spermatic veins in succession and the veins are occluded.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Maaynei Hayesha Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 17, 2008
Registry last updated
Mar 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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