NCT00877682

Brief Summary

The goal of this clinical research study is to learn if using cryotherapy to treat only the part of the prostate that contains cancer is an effective treatment for prostate cancer. The safety of this treatment will also be studied. Researchers also want to learn if treating only the part of the prostate with cancer causes less impact on your quality of life than other types of therapies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2009

Longer than P75 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

April 6, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2018

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

8.8 years

First QC Date

April 7, 2009

Last Update Submit

January 29, 2018

Conditions

Prostate Cancer

Keywords

Prostate CancerProstate TumorAdenocarcinoma of the ProstatePCARegional Prostate CryoablationCryotherapyCryoablationHealth Related Quality of LifeHRQOL

Outcome Measures

Primary Outcomes (1)

  • Patient Response

    Result of biopsy at 6 months after therapy. A failure event is either a Failure of Patient Selection or a Failure of Treatment.

    6 months

Study Arms (1)

Cryotherapy

EXPERIMENTAL

Under general anesthetic using ultrasonic guidance, freezing (cryoablation) portion of prostate.

Procedure: Cryoablation

Interventions

CryoablationPROCEDURE

Under general anesthetic using ultrasonic guidance, freezing (cryoablation) portion of prostate.

Also known as: Cryotherapy
Cryotherapy

Eligibility Criteria

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

You may qualify if:

  • Histologically identified adenocarcinoma of the prostate by minimum 6 core prostate biopsy.
  • Serum PSA \</= 10 ng/mL before prostate biopsy
  • Less than 50% of samples from one side of the prostate positive for prostate cancer.
  • No greater than 50% of a single core total length occupied by prostate cancer.
  • No dominant Gleason 4 component. (e.g.; 4+X is not allowed, but X+4 is eligible)
  • No Gleason 5 component (primary, secondary or tertiary).
  • In the case that the confirmatory biopsy fails to sample the tumor again, patients will be allowed to continue into the therapeutic phase using the laterality information obtained during the eligibility biopsy.

You may not qualify if:

  • Medical History or Concurrent Disease which in the investigators mind places the patient at significant preoperative risk or for which the investigator does not feel this therapy is appropriate. Investigator believes subject is unwilling or unable to comply with study protocol requirements.
  • AUASI (American Urologic Association Symptom Index) score \>/=20
  • Active urinary tract infection
  • Active treatment with anticoagulant/anti-platelet agent that cannot be safely stopped at the time of prostate biopsy and cryotherapy.
  • Medical or surgical castration initiated before or after the eligibility biopsy.
  • Patient is unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

CryosurgeryCryotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, OperativeTherapeutics

Study Officials

  • John F. Ward, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

April 6, 2009

Primary Completion

January 14, 2018

Study Completion

January 14, 2018

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

US(1)