Active Surveillance for Cancer of the Prostate (ASCaP)

Jonsson Comprehensive Cancer Center

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Other: Active surveillance

Study type: Observational

Funder types: Other

Identifiers

NCT00949819

11-002281

Details and patient eligibility

About

Active Surveillance (A.S.) of prostate cancer (CaP) is the systematic monitoring of men with low-risk, localized lesions, with curative treatment of those whose tumors show substantial progression. A.S. is different from Watchful Waiting (W.W.), which is the palliative treatment of men with progressive prostate cancer.

Full description

This protocol is not designed as a formal clinical trial, but rather an observational protocol; no treatments and no randomization are included. Longitudinally, specimens and clinical data will be collected to provide information on the following:

• Imaging studies of the prostate
• Rates of curative intervention
• Measures of tumor recurrence/progression
• Disease specific survival
• Overall survival
• Clinical data to track Quality of Life

Enrollment: 462 estimated patients

Sex: Male

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed adenocarcinoma of the prostate.
2. Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
3. No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
4. Patient has elected Active Surveillance as preferred management plan for prostate cancer.
5. Patient consent has been obtained according to local Institutional Review Board .
6. Patient is accessible and compliant for follow-up.

Exclusion criteria

1. Unwillingness or inability to undergo serial prostate biopsy.
2. Overall life expectancy less than 2 years
3. Advanced prostate cancer

Trial design

462 participants in 1 patient group

no treatment

Description:

Men with previously untreated, early stage prostate cancer.

Treatment:

Other: Active surveillance