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Recruiting

NCT Number: NCT00949819

Active Surveillance for Cancer of the Prostate (ASCaP)

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.

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

30 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Leonard S Marks, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Active Surveillance

Other

Serial, long term data collection and active surveillance

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Leonard S Marks, M.D.

CONTACT

[email protected]

(310) 794-3070

Malu Macairan

CONTACT

[email protected]

(310) 794-3566

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study title

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.

Acronym: ASCaP

Important dates

Study start
2009
Primary completion
2027
Study completion
2028
First posted
Jul 30, 2009
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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