Clinical trial · Observational
Quality of Life Study for Prostate Cancer Patients
A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients
NCT00561444CI-TRIAL-00042764unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this behavioral research study is to look at patients' quality of life after treatment or management for prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Quality of Life Study
- description
- Prostate cancer patients
- interventionNames
- Behavioral: Questionnaire
Primary outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.