Active Surveillance for Cancer of the Prostate (ASCaP)

NCT ID: NCT00949819

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

462 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-04

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

no treatment

Men with previously untreated, early stage prostate cancer.

Active surveillance

Intervention Type OTHER

Serial, long term data collection and active surveillance

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Active surveillance

Serial, long term data collection and active surveillance

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Leonard S Marks, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Malu Macairan

Role: CONTACT

(310) 794-3566

Leonard S Marks, M.D.

Role: CONTACT

(310) 794-3070

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11-002281

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.