Active Surveillance for Cancer of the Prostate (ASCaP) (ASCaP)

May 6, 2024 updated by: Jonsson Comprehensive Cancer Center

The UCLA ASCAP Project is an Observational, Longitudinal, and Open-ended Study Aimed at Establishing a Structured Program of Non-interventional Follow-up for Localized Prostate Cancer.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

462

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles
        • Principal Investigator:
          • Leonard S Marks, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
no treatment
Men with previously untreated, early stage prostate cancer.
Other: Active surveillance
Serial, long term data collection and active surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Interim data analysis will be made every year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Interim data analysis will be done each year
Interim data analysis will be done each year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

  • Principal Investigator: Leonard S Marks, M.D., University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2009

Primary Completion (Estimated)

July 5, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (Estimated)

July 30, 2009

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-002281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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