Active Surveillance for Cancer of the Prostate (ASCaP)

Recruiting

• Conditions: Prostate Cancer
• Interventions: Other: Active surveillance

• Registration Number: NCT00949819
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2009-07-04
• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-07-05
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 462

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
no treatment	Active surveillance	Men with previously untreated, early stage prostate cancer.

Primary Outcome Measures

Name	Time	Method
Discover and confirm clinical parameters that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables.	Interim data analysis will be made every year

Secondary Outcome Measures

Name	Time	Method
Determine the clinical predictors of disease progression. Measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer. Determine factors that lead to active intervention	Interim data analysis will be done each year

Trial Locations

Locations (1)

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States