Recruiting

Active SurveillanceActive Surveillance for Cancer of the Prostate (ASCaP)

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT00949819

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Active surveillance

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT00949819

Start date

Jul 4, 2009

Status verified date

May, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jul 5, 2027

Anticipated

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

462 participants

Anticipated

Interventions and Outcome Measures

Arms

no treatment

Men with previously untreated, early stage prostate cancer.

Interventions

Active surveillance

Serial, long term data collection and active surveillance

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Malu Macairan

(310) 794-3566 mmacairan@mednet.ucla.edu

Leonard S Marks, M.D.

(310) 794-3070 lmarks@mednet.ucla.edu

Locations

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Leonard S Marks, M.D.

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

Prostate Cancer
Low risk
Gleason 6
Active surveillance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-05-26.