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Quality of Life Study for Prostate Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00561444
Recruitment Status : Active, not recruiting
First Posted : November 21, 2007
Last Update Posted : January 14, 2020
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

Condition or disease Intervention/treatment
Prostate Cancer Behavioral: Questionnaire

Detailed Description:


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.

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Study Type : Observational
Actual Enrollment : 1051 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients
Actual Study Start Date : November 14, 2007
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Quality of Life Study
Prostate cancer patients
Behavioral: Questionnaire
Questionnaires taking 20 minutes to complete.
Other Name: Survey

Primary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with prostate cancer.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00561444

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United States, New Jersey
MD Anderson at Cooper
Voorhees, New Jersey, United States, 08043
United States, New Mexico
MD Anderson Cancer Center at Albuquerque
Albuquerque, New Mexico, United States, 87110
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Deborah A. Kuban, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00561444    
Other Study ID Numbers: 2007-0302
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Radical retropubic prostatectomy
Robotic prostatectomy
Photon external beam radiation
Photon external beam radiation with hormone therapy
Proton radiation
Radioisotopic implant
Quality of Life
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases