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Employing the treatment‐free interval of intermittent androgen ablation to screen candidate prostate cancer therapies
Author(s) -
Mao Shifeng,
Daliani Danai D.,
Wang Xuemei,
Thall Peter F.,
Do KimAnh,
Perez Cherie A.,
Brown Melissa A.,
Bouchillon Kathleen,
Carter Cindy M.,
Logothetis Christopher J.,
Kim Jeri
Publication year - 2007
Publication title -
the prostate
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.295
H-Index - 123
eISSN - 1097-0045
pISSN - 0270-4137
DOI - 10.1002/pros.20649
Subject(s) - medicine , prostate cancer , placebo , prostate , prostatectomy , urology , androgen , radiation therapy , hormonal therapy , antiandrogen , hormone therapy , cancer , oncology , surgery , hormone , pathology , breast cancer , alternative medicine
BACKGROUND Because neither continuous nor intermittent hormonal therapy is curative, we designed a clinical model to screen new drugs for additive or synergistic effects with hormonal therapy and used IM862, a naturally occurring dipeptide with antiangiogenic and immunomodulatory properties, to test it. METHODS Patients with prostate cancer who had rising PSA levels after radical prostatectomy and/or radiation therapy were given combined androgen ablation for 3 months. After 2 months' treatment, patients were randomly assigned in a double‐blind fashion to receive intranasal IM862 or placebo daily. Treatment continued for 6 months or until disease progression, which was defined by a rising serum PSA level, the appearance of new skeletal or extraskeletal metastatic disease, or new symptoms requiring intervention. RESULTS Seventy‐one patients were evaluable for response. Median time to PSA progression was not reached in either group. At 6 months, disease had progressed in 14 (41%) of the 34 patients receiving treatment and 18 (49%) of the 37 receiving placebo ( P = 0.39). No significant toxicities emerged. CONCLUSIONS The model was demonstrated to be an efficient platform for new drug screening; however, IM862, though well tolerated, failed to demonstrate superiority over placebo in prolonging time to PSA progression. Prostate 67: 1677–1685, 2007. © 2007 Wiley‐Liss, Inc.