NCT00489060

Brief Summary

A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
244

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
Completed

Started Dec 1997

Typical duration for phase_3 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

December 1, 1997

Completed
9.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
Last Updated

July 17, 2008

Status Verified

July 1, 2008

First QC Date

June 20, 2007

Last Update Submit

July 16, 2008

Conditions

Prostate Cancer

Keywords

CryoablationRadiationProstate Cancer

Outcome Measures

Primary Outcomes (1)

  • No evidence of disease progression (NEDP) at 36 months

    36 months

Secondary Outcomes (1)

  • Prostate biopsy status

    36 months post treatment

Interventions

Cryoablation and External Beam RadiationPROCEDURE

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically localized prostate cancer
  • PSA \< 20ng/ml
  • Negative bone scan

You may not qualify if:

  • Previous TURP
  • Previous hormone therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tom Baker Cancer Center

Calgary, Alberta, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Officials

  • Bryan Donnelly, MD

    Tom Baker Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 21, 2007

Study Start

December 1, 1997

Study Completion

April 1, 2007

Last Updated

July 17, 2008

Record last verified: 2008-07

Locations

CA(1)