Active Surveillance for Cancer of the Prostate (ASCaP)
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age30-85
SponsorJonsson Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed adenocarcinoma of the prostate.
Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
Patient has elected Active Surveillance as preferred management plan for prostate cancer.
Disqualifiers
Unwillingness or inability to undergo serial prostate biopsy.
Overall life expectancy less than 2 years
Advanced prostate cancer
Trial population
Community sample
Trial design
Design model
Ecologic or community
Time perspective
Prospective
Treatments tested in this trial
Active surveillance
Other interventionSerial, long term data collection and active surveillance
Treatment groups
462 Participants
are divided into 1 treatment groupGroup A: no treatment1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Interim data analysis will be made every yearSecondary outcomes
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
Time frame
Interim data analysis will be done each yearSponsors and contacts
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Source ClinicalTrials.gov