NCT00561444

Brief Summary

The goal of this behavioral research study is to look at patients' quality of life after treatment or management for prostate cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,051

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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 14, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

13 years

First QC Date

November 20, 2007

Last Update Submit

January 13, 2020

Conditions

Prostate Cancer

Keywords

Prostate CancerRadical retropubic prostatectomyRobotic prostatectomyPhoton external beam radiationPhoton external beam radiation with hormone therapyProton radiationRadioisotopic implantCryotherapyQuality of LifeQuestionnaireSurveyQOL

Outcome Measures

Primary Outcomes (1)

  • QOL: Expanded Prostate Cancer Index Composite (EPIC) Survey

    Survey prior to beginning treatment, 3 months after completing treatment, 6 months after completing treatment, at 6 month intervals for the first 2 years post-treatment, and then yearly for 3 more years.

Study Arms (1)

Quality of Life Study

Prostate cancer patients

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Questionnaires taking 20 minutes to complete.

Also known as: Survey
Quality of Life Study

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with prostate cancer.

You may qualify if:

  • Primary treatment at MD Anderson for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy, photon external beam radiation, photon external beam radiation with hormone therapy, proton radiation, radioisotopic implant, cryotherapy, or active surveillance.
  • Neoadjuvant, concurrent and adjuvant androgen ablation in conjunction with photon external beam radiation is allowed if not greater than 6 months total duration. Hormone therapy will be given as an LHRH agonist with or without an antiandrogen.
  • Pathologic diagnosis of prostate adenocarcinoma
  • AJCC (VI) stage T1-T3b N0M0
  • Ability to read, write, and fill out the self-survey questionnaires
  • Patients may be simultaneously enrolled on other MD Anderson treatment or laboratory protocols. The EPIC Survey will be used for both this protocol and for protocol 2007-0209 such that patients enrolled on both protocols will complete only one document at each survey point. Simultaneous enrollment on other survey protocols will be handled in a similar manner.

You may not qualify if:

  • Histology other than adenocarcinoma
  • Stage T4, nodal or distant metastasis
  • Prior treatment for prostate cancer except for neoadjuvant, concurrent and adjuvant androgen deprivation of 6 months or less duration in patients treated with photon radiation. Hormone therapy in all other modalities is not allowed.
  • Chemotherapy or molecular targeting therapy as primary, neoadjuvant or adjuvant treatment
  • Treatment for another pelvic malignancy, to include surgery or radiation
  • Treatment for another malignancy with chemotherapy completed within one year or less of treatment for prostate cancer.
  • Inflammatory bowel disease (eg. Crohn's or Ulcerative Colitis)
  • Patients 18 years or younger.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

MD Anderson at Cooper

Voorhees Township, New Jersey, 08043, United States

Location

MD Anderson Cancer Center at Albuquerque

Albuquerque, New Mexico, 87110, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Deborah A. Kuban, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 21, 2007

Study Start

November 14, 2007

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

US(3)