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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.


N/A
30 Years
85 Years
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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.


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


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

Type of Study:

Observational

Study Design:

Observational Model: Ecologic or Community, Time Perspective: Prospective

Outcome Measure:

Discover and confirm clinical parameters that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables.

Outcome Time Frame:

not specified

Safety Issue:

No

Principal Investigator

Leonard S Marks, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles

Authority:

IRB, USA:

Study ID:

ASCaP

NCT ID:

NCT00949819

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Low risk
  • Gleason 6
  • Active surveillance
  • Prostatic Neoplasms

Name

Location

University of California Los AngelesLos Angeles, California  90095-6951