Active Surveillance for Cancer of the Prostate (ASCaP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Leonard S. Marks, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00949819
First received: July 29, 2009
Last updated: December 10, 2013
Last verified: December 2013
  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: Active surveillace

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:


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: Interim data analysis will be made every year ] [ 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: Interim data analysis will be done each year ] [ 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
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
no treatment
Men with previously untreated, early stage prostate cancer.
Other: Active surveillace
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Leonard S. Marks, M.D., Primary Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00949819     History of Changes
Other Study ID Numbers: ASCaP
Study First Received: July 29, 2009
Last Updated: December 10, 2013
Health Authority: IRB, USA: UCLA

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 August 28, 2014