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

NCT ID: NCT00637208

Last Updated: 2008-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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prostate cancer venography male patients Localized microscopic prostate cancer up to Gleason 6 (3+3) PSA level <14 presence of varicocele

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

venographic occlusion of spermatic veins

Intervention Type PROCEDURE

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

2

Watch-full follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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venographic occlusion of spermatic veins

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Maaynei Hayesha Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maaynei Hayesha Medical Center

Locations

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Maaynei Hayesha Medical Center

Bnei Brak, , Israel

Site Status

Countries

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Israel

Other Identifiers

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MHMC grant

Identifier Type: -

Identifier Source: secondary_id

RVS-002-IL

Identifier Type: -

Identifier Source: org_study_id