Exisulind and Intermittent Androgen Suppression (ADT) in Biochemical Relapsed Prostate Cancer
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to determine if an investigational drug called
Exisulind will extend the "off-treatment" period of patients receiving Intermittent Androgen
Suppression (ADT).
There is evidence suggesting that alternating between periods of treatment and no treatment
with androgen suppressants may delay the time to develop androgen-insensitive progression and
improve overall quality of life. During intermittent androgen suppression (IAS) treatments,
men receive a luteinizing hormone-releasing hormone (LHRH) agonist and antiandrogen for a
fixed period of time (approximately 9 months) and then enter an off-treatment period, whose
length will vary, depending on the rate of rise in the patient's Prostate-Specific Antigen
(PSA). Once the PSA reaches an established threshold (1 ng/mL in men who have had a
prostatectomy or 4 ng/ml in men with an intact prostate), androgen suppression will be
re-initiated for another 9 months. These cycles of on-treatment/off-treatment will be
repeated until patient no longer responds to the androgen suppression and it is clear that
their cancer is progressing. It has been observed that off-treatment periods tend to become
shorter with each successive cycle of androgen suppression, presumably due to the emergence
of androgen-independent clones. This study proposes to look at exisulind, a pro-apoptotic
drug, which may extend the off-treatment period in patients receiving IAS.