Quality of Life Study for Prostate Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00561444
First received: November 20, 2007
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Behavioral: Questionnaire
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • QOL: Expanded Prostate Cancer Index Composite (EPIC) Survey [ Time Frame: 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1448
Study Start Date: November 2007
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Quality of Life Study
Prostate cancer patients
Behavioral: Questionnaire
Questionnaires taking 20 minutes to complete.
Other Name: Survey

Detailed Description:

Questionnaires:

You will complete 2 questionnaires that will ask you questions about your quality of life, urinary, bowel, sexual function, and any side effects that you may be having. You will be asked about any medications you may be taking and any other medical conditions you may have. The questionnaires will take about 20 minutes to complete. You may complete the questionnaires at the clinic, have them mailed to you (return postage will be included), or be asked the questions over the phone.

If you are on active surveillance (checking for prostate cancer by routine blood draws and biopsy, without active treatment), you will fill out the questionnaires on the same schedule as those receiving treatment that does not involve hormones.

If you are receiving therapy that does not involve hormones, you will complete the questionnaires before you receive treatment.

If you are receiving hormone therapy, you will complete the questionnaires before beginning the hormone therapy and then again within 3 weeks before starting radiation.

For all participants, at 3 and 6 months after the treatment is completed, you will complete the questionnaires again. Starting 6 months after you finish treatment, you will complete the questionnaires every 6 months for 2 years. Starting 2 years after treatment, you will complete the questionnaires once a year for 3 years.

Length of Study:

All participants will be considered off-study once they have completed the last questionnaires. You will be taken off study early if you receive a second treatment for prostate cancer or if you decide to have treatment while on active surveillance.

This is an investigational study. Up to 1448 patients will be enrolled in this study. All will be enrolled at MD Anderson, MD Anderson Albuquerque, and MD Anderson Cooper.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with prostate cancer.

Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Pathologic diagnosis of prostate adenocarcinoma
  4. AJCC (VI) stage T1-T3b N0M0
  5. Ability to read, write, and fill out the self-survey questionnaires
  6. 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.

Exclusion Criteria:

  1. Histology other than adenocarcinoma
  2. Stage T4, nodal or distant metastasis
  3. 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.
  4. Chemotherapy or molecular targeting therapy as primary, neoadjuvant or adjuvant treatment
  5. Treatment for another pelvic malignancy, to include surgery or radiation
  6. Treatment for another malignancy with chemotherapy completed within one year or less of treatment for prostate cancer.
  7. Inflammatory bowel disease (eg. Crohn's or Ulcerative Colitis)
  8. Patients 18 years or younger.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561444

Contacts
Contact: Deborah A. Kuban, MD 713-563-7382

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Deborah A. Kuban, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Deborah A. Kuban, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00561444     History of Changes
Other Study ID Numbers: 2007-0302
Study First Received: November 20, 2007
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Quality of Life
Radical retropubic prostatectomy
Robotic prostatectomy
Photon external beam radiation
Photon external beam radiation with hormone therapy
Proton radiation
Radioisotopic implant
Cryotherapy
Questionnaire
Survey
QOL

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014