Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01717053|
Recruitment Status : Active, not recruiting
First Posted : October 30, 2012
Results First Posted : September 24, 2018
Last Update Posted : February 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Abiraterone acetate Drug: Androgen deprivation Radiation: Radiation Therapy Drug: Prednisone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Abiraterone Acetate, Radiotherapy and Short-Term Androgen Deprivation in Men With Unfavorable Risk Localized Prostate Cancer|
|Actual Study Start Date :||January 17, 2014|
|Actual Primary Completion Date :||August 24, 2017|
|Estimated Study Completion Date :||August 2021|
Experimental: Abiraterone acetate
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Drug: Abiraterone acetate
1000 mg orally once a day for 6 months.
Other Name: Zytiga
Drug: Androgen deprivation
LHRH analog (at discretion of treating physician) will be administered over 6 months (for example, leuprolide acetate 22.5mg IM or goserelin acetate 10.8mg SC given every 3 months for 2 doses).
Radiation: Radiation Therapy
Daily (Monday-Friday) for 8 weeks, final dose of 75-80 Gy
5 mg tablet once daily for 6 months.
- Percentage of Patients With Undetectable PSA at 1 Year [ Time Frame: 1 year ]The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of <0.1 ng/mL.
- Time to PSA Nadir [ Time Frame: 1 year ]The median time in months to the lowest PSA value from the start of study therapy.
- PSA Nadir Value [ Time Frame: 1 year, 2 years ]The lowest PSA value from the start of study therapy.
- Biochemical Progression-free Survival [ Time Frame: up to 5 years ]Disease progression defined as Phoenix RTOG definition of nadir + 2ng/ml or initiation of salvage therapy
- Metastasis or Systemic Therapy [ Time Frame: up to 5 years ]Time to metastasis or systemic therapy
- Testosterone Recovery [ Time Frame: up to 5 years ]Time to testosterone recovery
- PSA < 1.5ng/ml in Setting of Non-castrate Testosterone [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]Proportion of men with 1, 2, 3, 4 and 5 year PSA < 1.5ng/ml in setting of non-castrate testosterone
- Safety and Tolerability [ Time Frame: 6 months ]The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717053
|United States, North Carolina|
|Durham Regional Hospital|
|Durham, North Carolina, United States, 27704|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bridget Koontz, MD||Duke University|