Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223665
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2005-09-16
Brief Title:
Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Prospective Study of Intermittent Androgen Suppression IAS in Men With Localized Prostate Cancer Who Have Biochemical Relapse After Radiation Therapy or Radical Prostatectomy
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:
IAS
Brief Summary:
This study was a prospective analysis in men with localized prostate cancer who had rising Prostate Specific Antigen PSA levels after definitive treatment with surgery or radiation Patients received Intermittent Androgen Suppression IAS in 9 month cycles until they became metastatic became castrate resistant or withdrew from the study Subjects were monitored for time to development of Castration Resistant Prostate Cancer CRPC and overall survival They were also monitored for the impact of IAS on a variety of neuro-psychiatric assessments and on bone density
Detailed Description:
The standard first line treatment for men with early stage newly diagnosed localized prostate cancer is a surgical removal of the prostate localized external beam radiation brachytherapy or a combination of surgery and radiation In most patients Prostate Specific Antigen PSA levels will decline after these localized treatments demonstrating a response to these therapies However despite an initial response to localized treatment some men will go on to later develop a rise in PSA levels an indicator of Biochemical Relapsed Prostate Cancer BRPC For BRPC patients who have not yet developed metastasis the standard treatment is Androgen Deprivation Therapy ADT to decrease levels of Testosterone subsequently decreasing PSA levels A low value for the PSA is more desirable as it may indicate no tumor growth
ADT may be administered as a continuous treatment Continuous Androgen Suppression or CAS or as intermittent treatment Intermittent Androgen Suppression or IAS This treatment is continued until the development of Castration Resistant Prostate Cancer CRPC indicated by a rise in PSA despite ADT Giving the hormone therapy intermittently in cycles of treatment and off treatment periods appears to delay the change of prostate cancer to a type of prostate cancer that resists hormone therapy prolonging efficacy of ADT monotherapy IAS may also decrease the impact of ADT on mental status
This study evaluated the effect of intermittent androgen suppression on time to androgen independent progression the development of castration resistant disease and overall survival in men with localized prostate cancer Subjects were also evaluated for the effects of intermittent androgen suppression on a variety of neuro-psychiatric assessments and on bone density
The subjects in this study had a rising PSA value after definitive therapy either with radical prostatectomy or external beam irradiation for the treatment of prostate cancer All subjects were males at or over the age of 21 years
New subjects were introduced to this study protocol along with other non-study treatment options during a clinic visit with Dr Higano or another sub-investigator After informed consent was obtained subjects underwent the following screening procedures before starting treatment Bone density scan DEXA Technetium-99 bone scan CT scan of the chest abdomen and pelvis blood draw and neuro-psychiatric assessments Subjects then began androgen suppression with a two-week lead-in of Flutamide followed by 9 monthly injections of Leuprolide Acetate During the treatment they had quarterly clinic visits and blood draws Their PSA levels were monitored monthly and if their PSA reached the appropriate nadir at by month 9 the androgen suppression was interrupted At the end of each treatment cycle subjects underwent another bone density test blood draw problem solving test and neuro-psychiatric assessments
During the off treatment phase the subject will again had quarterly clinic visits blood draws and neuro-psychiatric assessments PSA and testosterone were be monitored monthly Once the PSA reached the appropriate threshold the subject performed another set of screening procedures and resumed treatment for another 9 months This cycle continued until the patient withdrew from the study was taken off the study due to toxicities or the decision of the investigator or until the treatment with IAS was no longer effective in controlling the prostate cancer The neuro-psychiatric assessments were only performed during the subjects first cycle of treatment consisting of the 9 months on treatment and at month 3 of the off treatment period afterwards
ADT may be administered as a continuous treatment Continuous Androgen Suppression or CAS or as intermittent treatment Intermittent Androgen Suppression or IAS This treatment is continued until the development of Castration Resistant Prostate Cancer CRPC indicated by a rise in PSA despite ADT Giving the hormone therapy intermittently in cycles of treatment and off treatment periods appears to delay the change of prostate cancer to a type of prostate cancer that resists hormone therapy prolonging efficacy of ADT monotherapy IAS may also decrease the impact of ADT on mental status
This study evaluated the effect of intermittent androgen suppression on time to androgen independent progression the development of castration resistant disease and overall survival in men with localized prostate cancer Subjects were also evaluated for the effects of intermittent androgen suppression on a variety of neuro-psychiatric assessments and on bone density
The subjects in this study had a rising PSA value after definitive therapy either with radical prostatectomy or external beam irradiation for the treatment of prostate cancer All subjects were males at or over the age of 21 years
New subjects were introduced to this study protocol along with other non-study treatment options during a clinic visit with Dr Higano or another sub-investigator After informed consent was obtained subjects underwent the following screening procedures before starting treatment Bone density scan DEXA Technetium-99 bone scan CT scan of the chest abdomen and pelvis blood draw and neuro-psychiatric assessments Subjects then began androgen suppression with a two-week lead-in of Flutamide followed by 9 monthly injections of Leuprolide Acetate During the treatment they had quarterly clinic visits and blood draws Their PSA levels were monitored monthly and if their PSA reached the appropriate nadir at by month 9 the androgen suppression was interrupted At the end of each treatment cycle subjects underwent another bone density test blood draw problem solving test and neuro-psychiatric assessments
During the off treatment phase the subject will again had quarterly clinic visits blood draws and neuro-psychiatric assessments PSA and testosterone were be monitored monthly Once the PSA reached the appropriate threshold the subject performed another set of screening procedures and resumed treatment for another 9 months This cycle continued until the patient withdrew from the study was taken off the study due to toxicities or the decision of the investigator or until the treatment with IAS was no longer effective in controlling the prostate cancer The neuro-psychiatric assessments were only performed during the subjects first cycle of treatment consisting of the 9 months on treatment and at month 3 of the off treatment period afterwards
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSD 30296 | OTHER | University of Washington Human Subjects IRB | None |
| 973730AC06 | OTHER | None | None |