CClinicalTrials.gg
Status unknownNCT00561444Updated Jan 14, 2020

Quality of Life Study for Prostate Cancer Patients

An observational study in Prostate Cancer, sponsored by M.D. Anderson Cancer Center. Status unknown at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-14.

Sponsored by M.D. Anderson Cancer Center · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,051
Ages
18 Years and older
Sex
Male
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Study summary

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

Read the 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.

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Conditions studied

  • Prostate Cancer

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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
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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 1,051 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,051 participants (actual)

Groups and cohorts

  • Quality of Life Study

    Prostate cancer patients

    Behavioral: Questionnaire

Interventions

  • BehavioralQuestionnaire

    Questionnaires taking 20 minutes to complete.

    Also known as: Survey

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What researchers measure

Primary outcomes

  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.

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Study locations

3 sites
  • MD Anderson at Cooper
    Voorhees, New Jersey 08043, United States
  • MD Anderson Cancer Center at Albuquerque
    Albuquerque, New Mexico 87110, United States
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00561444
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Nov 21, 2007
Start date
Nov 14, 2007
Primary completion
Nov 2020 (estimated)
Completion
Nov 2020 (estimated)
Last update
Jan 14, 2020

Study contacts

Deborah A. Kuban, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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