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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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.


Inclusion Criteria:



1. Have signed an informed consent document indicating that the subjects understands the
purpose of and procedures required for the study and are willing to participate in
the study

2. Written Authorization for Use and Release of Health and Research Study Information
has been obtained

3. Be willing/able to adhere to the prohibitions and restrictions specified in this
protocol

4. Male patients >/= 18 years of age

5. Life expectancy >/= 12 months

6. ECOG Performance Status (PS)
7. Histologically documented diagnosis of adenocarcinoma of the prostate (PCa) with no
histologic variants

8. Prostate cancer recurrence after definitive local therapy (radical prostatectomy
and/or radiation therapy) as evidenced by rising serum PSA, without evidence of
metastases by bone scan or CT scan. a) After radiation: A rising PSA taken to
indicate recurrent prostate cancer in patients with previous definitive external beam
radiotherapy will be defined by the criteria of the American Society for Therapeutic
Radiology and Oncology as (nadir PSA + 2 ng/mL). For patients with prior definitive
brachytherapy, within 2 years of treatment the definition will be (nadir PSA + 3). ,
b) After Radical Prostatectomy: A rising PSA taken to indicate recurrent prostate
cancer in patients with previous radical prostatectomy will be defined by the
criteria of the American Urological Association as any PSA measurement of 0.2, with a
subsequent measurement >0.2 ng/mL

9. Patients who have received androgen ablative therapy for less than 8 weeks
immediately prior to initiation of study drug are eligible provided they had only PSA
evidence of progression (as defined above) with no visible metastases by CT-scan and
bone scan (within 4 weeks) prior to starting androgen ablation

10. Patients must have WBC >/= 3.5 x 10^9/L, ANC >/= 1.5 x 10^9/L, platelets >/= 100 x
10^9/L, Hb >/= 9.0 g/dL); total bilirubin upper limit of normal; serum potassium of >/= 3.5 mEq/L, serum albumin of >/= 3.0
g/dL, creatinine clearance >/= 60 mL/min

11. Patients must have recovered from prior treatment regimens, e.g. surgery, radiation

12. A patient who is sexually active and their partner must agree and use two reliable
barrier forms of contraception (for example, condoms and diaphragm), from first day
of study drug administration until for 1 week after last dose of abiraterone acetate,
unless partner is post-menopausal

13. Able to swallow the study drug whole as a tablet

14. Willing to take abiraterone acetate on an empty stomach; no food should be consumed
at least two hours before and for at least one hour after the dose of abiraterone
acetate is taken

Exclusion Criteria:

1. Patients who have received prior hormonal therapy are excluded from the trial, except
for: patients who have received up to 6 months of hormonal therapy as neoadjuvant
therapy before radical prostatectomy or while on radiation therapy, as long as more
than 1 year has elapsed between discontinuation of the neoadjuvant hormonal therapy
and initiation of hormonal treatment for relapsing disease

2. Any known metastases

3. Prolonged QTc interval on pre-entry electrocardiogram (>/= 450 msec)

4. Clinically significant heart disease as evidenced by myocardial infarction, or
arterial thrombotic events in the past 6 months, severe or unstable angina, or New
York Heart Association (NYHA) Class III-IV heart disease or cardiac ejection fraction
measurement of < 50% at baseline

5. Significant co-morbidity that could affect the safety or evaluability of
participants, including: a) chronically uncontrolled hypertension, defined
conventionally as consistent systolic pressures above 140 or diastolic pressures
above 90 despite therapy. Note that this is NOT a criterion related to particular BP
results at the time of assessment for eligibility, nor does it apply to acute BP
excursions that are related to iatrogenic causes, acute pain or other transient,
reversible causes, b) uncontrolled diabetes mellitus (defined as Hgb A1c > 8.5, or
symptomatic hypoglycemic episodes > 1 per week during the two months prior to
eligibility evaluation, or more than 1 glucose excursion to >300 mg/dL in prior two
months--unless clearly iatrogenic and the cause has been eliminated), c) lung disease
requiring supplemental oxygen, d) known chronic liver disease, or e) known HIV
infection

6. Prior therapy with strontium-89, samarium, rhenium-186 etidronate, anti-angiogenesis
therapy, chemotherapy or androgen biosynthesis inhibitors is not allowed. Previous
immunologic, homeopathic, natural, or alternative medicine therapies are acceptable
provided treatment ended greater than 28 days prior to initiation of study drug

7. Patients who, in the opinion of the investigator, are unable to comply with the
requirements of the study protocol are not eligible

8. Active infection or other medical condition that would make prednisone/prednisolone
(corticosteroid) use contraindicated

9. Active or symptomatic viral hepatitis

10. History of pituitary or adrenal dysfunction

11. Administration of an investigational therapeutic drug within 30 Days of Cycle 1 Day 1

12. Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or
prednisone or their excipients

13. Have a history of gastrointestinal disorders (medical disorders or extensive surgery)
that may interfere with the absorption of the study agents

14. Have a pre-existing condition that warrants long-term corticosteroid use in excess of
study dose

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prostate Specific Antigen (PSA) Free Survival

Outcome Description:

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%.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Christopher Logothetis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2012-0993

NCT ID:

NCT01786265

Start Date:

February 2013

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • PSA Progression After Prostatectomy and/or Radiotherapy
  • Prostate specific antigen
  • PSA
  • Luteinizing-hormone-releasing hormone
  • LHRH
  • Finite maximal androgen ablation
  • Lupron
  • Leuprolide Acetate
  • Lupron Depot
  • Zoladex
  • Goserelin
  • Degarelix
  • Abiraterone Acetate
  • Zytiga
  • Prednisone
  • Prostatic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030