S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT

SWOG Cancer Research Network

Status: Terminated

Conditions: Prostate Cancer

Treatments: Other: Follow-up

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00288106

U10CA012027 (U.S. NIH Grant/Contract)

S0437 (Other Identifier)

CDR0000466341

Details and patient eligibility

About

RATIONALE: Learning about the long-term effects of chemoprevention drugs, such as finasteride, in patients with prostate cancer may help doctors plan better treatment and follow-up care.

PURPOSE: This clinical trial is following patients who were diagnosed with prostate cancer while undergoing treatment with either finasteride or a placebo on the Prostate Cancer Prevention Trial (PCPT).

Full description

OBJECTIVES:

• Compare the time to metastases in patients who were diagnosed with high grade or low grade prostate cancer on or before December 31, 2003 and were treated with finasteride or placebo while enrolled on the Prostate Cancer Prevention Trial (SWOG-9217).
• Compare the difference in time to secondary therapy after definitive therapy with radiotherapy or radical prostatectomy in these patients.
• Compare the difference in time to prostate-specific antigen recurrence after definitive therapy with radiotherapy or radical prostatectomy in these patients.
• Compare the difference in all-cause and prostate cancer mortality in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to survival status (alive vs deceased).

Patients provide information about their general health, prostate cancer treatment history, prostate cancer status (i.e., disease progression and metastases data), and prostate-specific antigen (PSA) test results at baseline and then every 6 months for up to 8 years. Next of kin of deceased patients are asked to release the patients' medical records in order to obtain information about the patients' prostate cancer treatment history, prostate cancer progression and metastases, PSA test results, and cause of death.

PROJECTED ACCRUAL: A minimum of 75% of the 2,401 patients (n=1800) diagnosed with prostate cancer on PCPT are needed to have minimal power to evaluate the objectives.

Enrollment: 961 patients

Sex: Male

Ages: 55 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA:

• Randomized on PCPT
• Diagnosed with prostate cancer on or before December 31, 2003

DISEASE CHARACTERISTICS:

• Diagnosed by either study site or central pathology review

PATIENT CHARACTERISTICS:

• See inclusion criteria

PRIOR CONCURRENT THERAPY:

• Not Applicable

Trial design

961 participants in 1 patient group

Long Term Follow-Up

Description:

Follow-up data collection study for men who developed prostate cancer after participation in SWOG-9217 (PCPT)

Treatment:

Other: Follow-up