Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1051 participants
OBSERVATIONAL
2007-11-14
2020-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Quality of Life Study
Prostate cancer patients
Questionnaire
Questionnaires taking 20 minutes to complete.
Interventions
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Questionnaire
Questionnaires taking 20 minutes to complete.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
MALE
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Deborah A. Kuban, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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MD Anderson at Cooper
Voorhees Township, New Jersey, United States
MD Anderson Cancer Center at Albuquerque
Albuquerque, New Mexico, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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The University of Texas M.D.Anderson Cancer Center
Other Identifiers
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2007-0302
Identifier Type: -
Identifier Source: org_study_id
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