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A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

QOL: Expanded Prostate Cancer Index Composite (EPIC) Survey

Outcome 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.

Safety Issue:

No

Principal Investigator

Deborah A. Kuban, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0302

NCT ID:

NCT00561444

Start Date:

November 2007

Completion Date:

Related Keywords:

  • Prostate Cancer
  • 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
  • Prostatic Neoplasms

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030