Clinical trial NCT00582842: Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer
Official title: Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Early Stage
Localized
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 1800
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible MSKCC patients (including patients from the regional network sites: Commack, Basking Ridge, Rockville Centre and Sleepy Hollow) will be approached by consenting professionals and invited to participate in the study.

Brief summary: The purpose of this study is to assess quality-of-life of men with prostate cancer. "Quality-of-life" means how you feel about your life as a result of your disease and its treatment. The investigators hope that this questionnaire will help show how prostate cancer treatments affect quality-of-life. It will help doctors and future patients to make better treatment choices. Some men may wish to have a more demanding treatment with a higher risk of harmful effects. Others may prefer a treatment that will have the smallest effect on their quality-of-life.

This questionnaire will help us measure these effects and decide which is the best treatment for a given patient.

Detailed description: The intent of the protocol is to assess health-related quality-of-life (HRQOL) in men treated for localized prostate cancer with 1 of 6 established management alternatives: external (XRT)or interstitial radiotherapy (IRT), open radical prostatectomy (RP), laparoscopic radical prostatectomy (LRP), combined radiotherapy and brachytherapy (Combined RT) or watchful waiting (WW). HRQOL is an important aspect of any treatment for prostate cancer due to the beliefs by many that cancer control rates are similar across common modalities and HRQOL reduction from treatment is substantial (1-5). Therefore, HRQOL appears to occupy a central role in the decision making process related to treatment selection.

Eligibility criteria: Inclusion Criteria:

* diagnosis of localized, untreated prostate cancer (clinical stages T1-3, Nx, M0)
* ability to read the English language

Exclusion criteria:

* other cancer diagnosis for the past three years, except for non-melanoma skin cancer
* prior chemotherapy within the last three years; radiation therapy to the pelvis or prior pelvic surgery within the past three years
* prior neoadjuvant therapy, such as hormones (Bicalutamide use for less than or equal to 1 month would not constitute exclusion from study entry)

For the cross-sectional component of the study, all patients identified to be free of disease at least ten years post -treatment will be considered eligible. Patients must have no clinical evidence of local, regional or distant recurrences. Patients must have the ability to read and understand English. Patients who received hormonal therapy will be eligible for the cross-sectional component of the study, but the duration of the hormonal therapy must be six months or less. the investigators have identified a cohort of patients who fit these criteria from our databases.

Primary outcomes:
measure: Assessment of temporal trends in HRQOL according to intervention group
timeFrame: study time points 3, 6, 9, 12, 15, 18, 24, 36, and 48 following treatment)and between 60 and 96 months.
Secondary outcomes:
measure: Assessment of scale score differences between treatment groups
timeFrame: 3, 6, 9, 12, 15, 18, 24, 36, 48 months and between 60 and 96 months
measure: Describe the quality of life of long-term survivors
timeFrame: 10 years post treatment
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering Cancer Center
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memoral Sloan Kettering Cancer Center@Phelps
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Peter Scardino, M.D.
role: PRINCIPAL_INVESTIGATOR
References: