Clinical trial NCT00561444: Quality of Life Study for Prostate Cancer Patients
Official title: A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Radical retropubic prostatectomy
Robotic prostatectomy
Photon external beam radiation
Photon external beam radiation with hormone therapy
Proton radiation
Radioisotopic implant
Cryotherapy
Quality of Life
Questionnaire
Survey
QOL
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-11-21
Enrollment: 1051
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with prostate cancer.

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

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 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.

Primary outcomes:
measure: QOL: Expanded Prostate Cancer Index Composite (EPIC) Survey
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Voorhees
country: United States
facility: MD Anderson at Cooper
state: New Jersey
city: Albuquerque
country: United States
facility: MD Anderson Cancer Center at Albuquerque
state: New Mexico
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Deborah A. Kuban, MD
role: PRINCIPAL_INVESTIGATOR
References: