Active Surveillance for Cancer of the Prostate (ASCAP)

Active Surveillance for Cancer of the Prostate (ASCAP): An Observational Study to Help Us Monitor and Learn More About Prostate Cancer

Technical Title: Active Surveillance for Cancer of the Prostate (ASCAP)

Disease Type: Low risk prostate cancer

Basic information:
This observational study looks at patients with evidence of "low-risk" prostate cancer that does not require immediate treatment.  Many men found to have prostate cancer have such a small amount of tumor that any future growth or spread is unlikely. This study helps researchers learn more about the natural history and factors leading to progression or stabilization of these small prostate tumors.  In this program, patients are followed indefinitely, until they elect to withdraw, or are advised by the researchers that they need to seek prostate cancer treatment.

Research Procedures (not a complete list):
Patients will be invited to participate in this study after evidence of low-risk prostate cancer is diagnosed following prostate biopsy. Patients who enroll will be asked annually to participate in optional questionnaires to collect quality-of-life data and optional blood draws for future biomarker testing. Follow-up assessments, such as PSA blood draw and prostate exam, will be done every 6 months according to conventional care standards. MRI-targeted fusion biopsies will be performed as deemed necessary by a health care provider.

Eligibility Criteria (not a complete list):
Inclusion Criteria:

• Diagnosis of clinically localized (T1 to T2) prostate cancer
• Patient elects active surveillance as preferred management plan for prostate cancer

Exclusion Criteria:

• Patient is unwilling to undergo prostate biopsy

For More Detailed Information, Contact:

• Leonard Marks, MD, Principal Investigator
• Merdie Delfin, NP, Study Coordinator

Read more about this study (NCT00949819) on ClinicalTrials.gov.