Abstract
Characteristics of the screen-failure (SF) patient population in an early castrate-resistant prostate cancer vaccine clinical trial: Lessons for future trial design
Journal of clinical oncology, Vol.30(5_suppl), pp.241-241
02/10/2012
DOI: 10.1200/jco.2012.30.5_suppl.241
Abstract
241
Background: AdPSA is an investigational replication-deficient adenovirus-based PSA vaccine. A prior phase I trial in patients (pts) with metastatic CRPC showed safety and ability to generate immune responses. We are conducting a phase II trial in early CRPC in our comprehensive cancer center + VA. This study contains an analysis of the SF (post-informed consent) population.
Methods: Patients with CRPC defined as rising PSA despite androgen deprivation therapy are eligible for this trial. Main eligibility criteria requires a bone scan, chest X-ray and abdomen pelvis CT without evidence of metastatic disease (any PSA or PSA doubling time allowed). Pts with metastatic disease are also eligible if they have a PSA doubling time greater than 6 months and a PSA less than 10 and are asymptomatic. Prior antiandrogens or ketoconazole are allowed, provided the PSA is rising. Prior chemotherapy or sipuleucel-T is not allowed.
Results: 38 pts have been consented for the clinical trial, of which 21 pts have proceeded with study therapy. 17 pts were SF for the following reasons: 13 had positive CT and/or bone scans with exclusionary PSA or PSADT values, 1 had declining PSA prior to starting therapy, and for 3 pts initiation of study therapy was contraindicated (second cancer discovered on CT, aggressive pace of progression, and unrelated patient death). Median PSA was 10.2 for SF vs 1.9 ng/mL for treated pts. 6 SF patients had PSA < 5 ng/mL. 26 pts had prior bicalutamide (12 SF, 14 treated group). Prior ketoconazole was rare in both groups. The vast majority of pts who were treated did not have metastatic disease.
Conclusions: In a large academic cancer center, it is challenging but possible to find patients with early non-metastatic CRPC. Higher PSA may predict SF, but several patients with PSA < 5 ng/mL also had metastases on screen. Prior antiandrogen is not a predictor for SF. Since this abstract only relates to patients who consented for the trial, the denominator of cancer center patients with early CRPC (but not eligible) is even larger. This information will help accrual estimates in cancer centers and feasibility assessment of early CRPC studies.
Details
- Title: Subtitle
- Characteristics of the screen-failure (SF) patient population in an early castrate-resistant prostate cancer vaccine clinical trial: Lessons for future trial design
- Creators
- Daniel A. VaenaPamela ZehrKaren GriffithErica BrownJames A BrownJulie EastmanDavid Lubaroff
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.30(5_suppl), pp.241-241
- DOI
- 10.1200/jco.2012.30.5_suppl.241
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Language
- English
- Date published
- 02/10/2012
- Academic Unit
- Roy J. Carver Department of Biomedical Engineering; Internal Medicine; Urology
- Record Identifier
- 9984321439102771
Metrics
10 Record Views