NCT00637208

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2007

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
Last Updated

March 17, 2008

Status Verified

March 1, 2008

Enrollment Period

4 months

First QC Date

March 9, 2008

Last Update Submit

March 14, 2008

Conditions

Prostate Cancer

Keywords

prostate cancervenographymale patientsLocalized microscopic prostate cancer up to Gleason 6 (3+3)PSA level <14presence of varicocele

Outcome Measures

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

    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

    one year

Study Arms (2)

1

EXPERIMENTAL
Procedure: venographic occlusion of spermatic veins

2

NO INTERVENTION

Watch-full follow-up

Interventions

venographic occlusion of spermatic veinsPROCEDURE

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

1

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males age 45-75
  • Prostate cancer
  • Presence of varicocele
  • No contraindication for venography

You may not qualify if:

  • Diseases or medications which prevent interventional vascular procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maaynei Hayesha Medical Center

Bnei Brak, 51544, Israel

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2008

First Posted

March 17, 2008

Study Start

November 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 17, 2008

Record last verified: 2008-03

Locations

IL(1)