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Active Surveillance for Cancer of the Prostate (ASCaP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00949819
First received: July 29, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Prostate Cancer
 Other: Observational

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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: not specified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: not specified ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, plasma, buffy coat, prostate tissue cores and urine.


Estimated Enrollment: 6
Study Start Date: June 2009
Groups/Cohorts Assigned Interventions
low-risk prostate cancer
Men with previously untreated, early stage prostate cancer.
 Other: Observational
Serial, long term data collection

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
  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949819

Contacts
Contact: Malu Macairan (310) 794-3566 mmacairan@mednet.ucla.edu
Contact: Leonard S Marks, M.D. (310) 794-3070 lmarks@mednet.ucla.edu

Locations
United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Leonard S Marks, M.D.            
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Leonard S Marks, M.D. University of California, Los Angeles
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Leonard S. Marks, M.D., UCLA
ClinicalTrials.gov Identifier: NCT00949819     History of Changes
Other Study ID Numbers: ASCaP
Study First Received: July 29, 2009
Last Updated: July 29, 2009
Health Authority: IRB, USA:

Keywords provided by University of California, Los Angeles:
Prostate Cancer
Low risk
Gleason 6
Active surveillance

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013