Active Surveillance for Cancer of the Prostate (ASCaP)

• Sponsor: Jonsson Comprehensive Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT00949819
• Collaborator: (none)
• Enrollment: 462
• Location: 1
• Anticipated Duration (Months): 232.9
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: Active surveillance

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 Design

• Study Type: Observational
• Anticipated Enrollment: 462 participants
• 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.
• Actual Study Start Date: Jul 4, 2009
• Anticipated Primary Completion Date: Jul 5, 2027
• Anticipated Study Completion Date: Dec 1, 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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. [Interim data analysis will be made every year]

Secondary Outcome Measures

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 [Interim data analysis will be done each year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 85 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of California Los Angeles	Los Angeles	California	United States	90095

Sponsors and Collaborators

• Jonsson Comprehensive Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonsson Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT00949819
• Other Study ID Numbers: 11-002281
• First Posted: Jul 30, 2009
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jonsson Comprehensive Cancer Center: Prostate Cancer; Low risk; Gleason 6; Active surveillance
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Apr 20, 2022