Know Cancer

forgot password

Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer

Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer

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.

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Assessment of temporal trends in HRQOL according to intervention group

Outcome Time Frame:

study time points 3, 6, 9, 12, 15, 18, 24, 36, and 48 following treatment)and between 60 and 96 months.

Safety Issue:


Principal Investigator

Peter Scardino, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2002

Completion Date:

May 2014

Related Keywords:

  • Prostate Cancer
  • Early Stage
  • Localized
  • Prostatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Memoral Sloan Kettering Cancer Center Basking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ Suffolk Commack, New York  11725
Memorial Sloan-Kettering at Mercy Medical Center Rockville Centre, New York  
Memoral Sloan Kettering Cancer Center@Phelps Sleepy Hollow, New York