Multimodality Therapy for Recurrent High Risk Prostate Cancer: A Phase II Study
In many common malignancies such as breast cancer, trimodality therapy represents the
standard-of-care approach, including initial surgical resection followed by systemic
chemotherapy followed by radiotherapy for optimal local control, and targeted hormonal or
biologic therapy for a period of time to reduce the ongoing risk of systemic disease
recurrence. These approaches have reduced recurrence rates and improved overall survival in
the adjuvant setting in breast cancer; however, the treatment of men with PSA recurrence
following radical prostatectomy has generally been unsatisfying, given the high rates of
persistent or recurrent disease despite salvage radiotherapy.
The primary purpose of the study is to determine the rate of biochemical (PSA) progression
free survival (bPFS) in men with PSA recurrent non-metastatic prostate cancer following
radical prostatectomy, who receive multimodality therapy consisting of local salvage
external beam radiotherapy and systemic docetaxel-based chemotherapy plus the targeted
anti-VEGF biologic therapy sunitinib. Biochemical PFS will be defined as the proportion of
subjects at 24 months, post-registration, with one of the following: 1) a serum PSA value
of 0.2 ng/ml or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a
second PSA measurement that was higher than the first by any amount, 2) a continued rise in
the PSA level following study treatment if no nadir is experienced, defined as 2 rising
values greater than the baseline PSA and separated by at least 4 weeks, 3) evidence of
clinical progression or initiation of systemic therapy for progressive disease, or 4) death.
Secondary objectives include finding the rate of biochemical (PSA) disease free survival
over time, Two-, three-, five-, and six- year risk of local recurrence (proportion), two-,
three-, five-, and six-year risk of metastases and metastasis-free survival, two-, three-,
five-, and six-year risk of metastases and metastasis-free survival, Safety, feasibility,
and tolerability as assessed by NCI Common Toxicity Scales (v3.0), quality of life
questionnaire (EPIC-short form surveys), achievement of accrual goals. Finally, a
comparison of RNA expression profiles from original prostate radical prostatectomy specimen
among those with PSA relapse at 2 and 5 years as compared to those without PSA relapse at
the primary endpoint.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective is the rate of progression free survival (PFS) at 24 months
2 years
No
Andrew J Armstrong, MD, ScM
Principal Investigator
Duke University
United States: Food and Drug Administration
Pro00010747
NCT00734851
December 2008
April 2015
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Duke University | Durham, North Carolina 27710 |
The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |