Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283803
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2006-01-26
Brief Title:
Exisulind and Intermittent Androgen Suppression ADT in Biochemical Relapsed Prostate Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
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 ADT
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients Prostate-Specific Antigen PSA Once the PSA reaches an established threshold 1 ngmL in men who have had a prostatectomy or 4 ngml in men with an intact prostate androgen suppression will be re-initiated for another 9 months These cycles of on-treatmentoff-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
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 patients Prostate-Specific Antigen PSA Once the PSA reaches an established threshold 1 ngmL in men who have had a prostatectomy or 4 ngml in men with an intact prostate androgen suppression will be re-initiated for another 9 months These cycles of on-treatmentoff-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
Detailed Description:
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 Prostate-Specific Antigen PSA If not already obtained you will have a bone scan and a computed tomography scan CT scan to establish a baseline
You will be receiving hormone suppression treatment with monthly injections of a luteinizing hormone-releasing hormone LHRH 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 10 ngdL If you have an intact prostate your threshold is 4 ngdL Once your PSA reaches this level you will restart your hormone suppression treatment as directed by your doctor
You will be receiving hormone suppression treatment with monthly injections of a luteinizing hormone-releasing hormone LHRH 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 10 ngdL If you have an intact prostate your threshold is 4 ngdL Once your PSA reaches this level you will restart your hormone suppression treatment as directed by your doctor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EX1006 | OTHER | OSI Pharmaceuticals | None |