To Lengthen the Duration of the Off-Treatment of Intermittent Androgen Suppression
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.
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 an 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 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.
Drug: Leuprolide Acetate
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Effect of Exisulind on the Duration of the "Off-Treatment" Interval on Patients With Biochemical Relapse of Prostate Cancer Who Are Treated With Intermittent Androgen Suppression|
- To determine whether the addition of exisulind to the treatment of patients who have completed at least ONE cycle of IAS will extend the "off-treatment" cycle. [ Time Frame: to be determined ]
- To determine the time to hormone-refractory diseases in the patients who are taking exisulind with IAS [ Time Frame: to be determined ]
|Study Start Date:||October 2001|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
250 mg tidDrug: Leuprolide Acetate
7.5 mg q month
Other Name: LupronDrug: Exisulind
Exisulind 125 mg
Other Name: no other names
A study doctor will meet with you and ask you about your medical history, examine you, and explain the study. We will draw some blood for tests (about 4-6 tablespoons), including PSA. If not already obtained, you will have a bone scan and a CT scan to establish a baseline.
You will be receiving hormone suppression treatment with monthly injections of an LH-RH analog such as Lupron or Zoladex and an antiandrogen such as Eulexin or Casodex as part of your standard care for prostate cancer. About 3 months before your next "off-treatment" period, you will start 1 Exisulind pill 250 mg (2 x 125mg capsules) by mouth twice a day. It is necessary for you to start the Exisulind treatment 3 months prior to your next "off-treatment" period so that the medication can build up in your system enough to be effective.
Per our standard follow-up procedures, we will ask you to have blood draws every 2 weeks for up to 12 weeks after starting Exisulind to check liver function. Thereafter you will be asked to have monthly blood draws, and return to the clinic every 3 months for a physical examination, to determine how well you are tolerating the study medication, how your cancer is responding to the treatment, and to give you more study medication. You will continue taking Exisulind during your "off-treatment" period until your PSA reaches a threshold level. PSA threshold is defined by your primary treatment. If you have had your prostate removed, the threshold is 1.0 ng/dL. If you have an intact prostate, your threshold is 4 ng/dL. Once your PSA reaches this level, you will restart your hormone suppression treatment as directed by your doctor.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283803
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Celestia Higano, MD||University of Washington|