A Randomized Study of Finite Androgen Ablation vs. Finite Androgen Ablation in Combination With Abiraterone Acetate and Prednisone in Patients With Prostate Cancer Who Have PSA Progression After Prostatectomy and/or Radiotherapy
Study Groups and Study Drug Administration:
If you are found to be eligible to take part in this study, you will be randomly assigned
(like the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned
to each group.
If you are in Group 1, you will receive standard of care hormonal therapy. The study doctor
will decide what hormone therapy you will receive and will explain when and how you should
take the hormone therapy and any risks.
If you are in Group 2, you will also receive standard of car hormone therapy. In addition,
you will take 4 abiraterone acetate tablets by mouth each day at least 1 hour before a meal
and 2 hours after a meal. You will also take prednisone every day.
About every 28-days is considered a "cycle." You should return all unused study drug and/or
empty pill bottles at the end of each cycle.
Study Visits:
Every 2 weeks (for the first 12 weeks), if you are in Group 2, blood (about 1-2 tablespoons)
will be drawn to test your liver function. These tests may be done at a local facility and
results faxed to MD Anderson.
On Day 1 of Even Cycles (2, 4, 6, and so on):
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will be asked about any side effects you may have had and any drugs or treatments
you may be receiving.
- Blood (about 2 tablespoons) will be drawn for routine tests, to check your liver
function, and for PSA testing.
On Day 1 of Odd Cycles (1, 3, 5, and so on):
- You will have a physical exam, including measurement of your weight and vital signs.
- You will be asked about any side effects you may have had and any drugs or treatments
you may be receiving.
- Blood (about 2 tablespoons) will be drawn for routine tests, to check your liver
function, and for PSA and testosterone testing.
- You will have a bone scan to check the status of the disease
- You will have a chest x-ray and CT scans to check the status of the disease. If you are
unable to return to MD Anderson, follow-up scans may be done at a local facility. The
scans should be sent to MD Anderson for review.
Length of Study:
You may receive the study drugs for up to 8 cycles. You will no longer be able to take the
study drug if the disease gets worse, if intolerable side effects occur, or if you are
unable to follow study directions.
Your participation on the study will be over after the follow-up visits.
End of Treatment Visit:
When you are no longer taking the study drugs:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- You will be asked about any side effects you may have had and any drugs or treatments
you may be receiving.
- Blood (about 3-4 tablespoons) will be drawn for routine tests, to check your liver
function, and to check your PSA and your testosterone level.
- You will have a bone marrow aspirate and biopsy performed to check the status of your
disease.
Long-Term Follow-Up:
Every 3 months, blood (about 1 teaspoon) will be drawn to test your PSA level. This may be
done at your local physician's office and the results faxed to MD Anderson.
Every 6 months:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- You will be asked about any side effects you may have had and any drugs or treatments
you may be receiving.
- Blood (about 3 tablespoons) will be drawn for routine tests, to check your liver
function, your PSA level and your testosterone level.
The follow-up visits will continue as long as the disease is stable.
Extension Crossover Study Phase:
If the disease gets worse while you are on study, you will be eligible for the extension
phase. If you received hormone therapy alone, you will be treated with the combination of
hormones and abiraterone acetate plus prednisone for 8 months. If you received the
combination therapy, you will receive hormone therapy alone.
If you crossover to the other treatment group on this study, you will have a bone marrow
aspirate and biopsy collected to check the status of your disease. The schedule for visits
in the extension study will be identical to the schedule described above. When you have
completed the additional 8 months of treatment, and an additional follow-up period (lasting
as long as the disease is stable), you will have another bone marrow aspirate and biopsy
performed.
This is an investigational study. Abiraterone acetate is FDA approved in combination with
prednisone for the treatment of patients with metastatic castration-resistant prostate
cancer who have received prior chemotherapy containing docetaxel. Prednisone is FDA
approved and commercially available as a corticosteroid. The use of hormone therapy in
combination with abiraterone and prednisone in patients with prostate cancer is
investigational.
Up to 200 patients will be take part in this study. All will be enrolled at MD Anderson.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Prostate Specific Antigen (PSA) Free Survival
Primary endpoint is PSA free survival (PSA < 0.1 ng/ml) at 12 months after treatment. Estimation made whether finite maximal androgen ablation (8 month) as compared to LHRH Alone will improve one year post-treatment PSA free survival by 20%.
12 months
No
Christopher Logothetis, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2012-0993
NCT01786265
February 2013
Name | Location |
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UT MD Anderson Cancer Center | Houston, Texas 77030 |