Active Surveillance for Cancer of the Prostate (ASCaP)

Prostate Cancer Clinical Trial

— ASCaP  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00949819
• Other study ID #: 11-002281
• Status: Recruiting
• Start date: July 4, 2009
• Est. completion date: December 2028

Study information

• Verified date: May 2024
• Source: Jonsson Comprehensive Cancer Center
• Contact: Malu Macairan
• Phone: (310) 794-3566
• Email: mmacairan[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 462
• Est. completion date: December 2028
• Est. primary completion date: July 5, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Active surveillance
Serial, long term data collection and active surveillance

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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