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Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent 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: NCT01786265
Recruitment Status : Active, not recruiting
First Posted : February 7, 2013
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE February 5, 2013
First Posted Date  ICMJE February 7, 2013
Last Update Posted Date November 19, 2021
Actual Study Start Date  ICMJE February 5, 2013
Estimated Primary Completion Date February 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2020)		 Prostate-specific antigen (PSA) free survival (PSA < 0.1 ng/ml) [ Time Frame: At 12 months after treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2013)		 Prostate Specific Antigen (PSA) Free Survival [ Time Frame: 12 months ]
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%.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer
Official Title  ICMJE 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
Brief Summary This phase II trial studies how well finite androgen ablation with or without abiraterone acetate and prednisone work in treating patients with prostate cancer that has come back. Androgen can cause the growth of prostate cancer cells. Hormone therapy, such as finite androgen ablation, using leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, and nilutamide may fight prostate cancer by lowering the amount of androgen the body makes. Abiraterone acetate may help to decrease the production of testosterone, and prednisone may help lower or prevent some side effects. It is not yet known whether giving acetate, goserelin acetate, degarelix, bicalutamide, flutamide, and nilutamide with or without abiraterone acetate and prednisone may work better in treating patients with prostate cancer.
Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate whether finite maximal androgen ablation (8 month), as compared to luteinizing-hormone-releasing hormone (LHRH) alone, will improve one-year post-treatment prostate specific antigen (PSA)-free survival by 20%.

SECONDARY OBJECTIVES:

I. To determine testosterone recovery difference between the two groups. II. Calculate the PSA-free survival following testosterone recovery. III. To determine in the steroid biosynthesis metabolome, in the blood and bone marrow of patients at baseline, maximum response (eight months therapy) and upon PSA progression, evidence of minimal residual cancer (MD Anderson Cancer Center [MDACC] main campus patients only).

IV. To apply technologies in development able to detect presence of cancer cells ("minimal residual disease") at a clinical study milestone (baseline, completion of therapy and upon PSA progression).

EXPLORATORY OBJECTIVE:

I. To explore in archival tissue samples for a candidate predictive signature of outcome applying technologies for interrogation of protein deoxyribonucleic acid (dna) and ribonucleic acid (rna) levels of molecular markers / pathways of interest.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive either leuprolide acetate via injection every month or every 4 months, goserelin acetate via injection every month, or degarelix via injection every month for 8 months. Patients also receive bicalutamide orally (PO) once daily (QD), flutamide PO three times daily (TID), or nilutamide PO QD. Patients may crossover to Arm B with disease progression after 8 months.

ARM B: Patients receive leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, or nilutamide as in Arm A. Patients also receive abiraterone acetate PO daily for 8 months and prednisone daily. Patients may crossover to Arm A with disease progression after 8 months.

After completion of study treatment, patients are followed up every 3 and 6 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Adenocarcinoma
  • Recurrent Prostate Carcinoma
Intervention  ICMJE
  • Drug: Abiraterone Acetate
    Given PO
    Other Names:
    • CB7630
    • Yonsa
    • Zytiga
  • Drug: Bicalutamide
    Given PO
    Other Names:
    • Casodex
    • Cosudex
    • ICI 176,334
    • ICI 176334
  • Drug: Degarelix
    Given via injection
    Other Names:
    • FE200486
    • Firmagon
  • Drug: Flutamide
    Given PO
    Other Names:
    • 4''-Nitro-3''-trifluoromethylisobutyranilide
    • Apimid
    • Cebatrol
    • Chimax
    • Cytomid
    • Drogenil
    • Euflex
    • Eulexine
    • Flucinom
    • Flucinome
    • Flugerel
    • Fluken
    • Flulem
    • FLUT
    • Fluta-Gry
    • Flutabene
    • Flutacan
    • Flutamex
    • Flutamin
    • Flutan
    • Flutaplex
    • Fugerel
    • Grisetin
    • Niftolide
    • Oncosal
    • Profamid
    • Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
    • Prostacur
    • Prostadirex
    • Prostica
    • Prostogenat
    • Sch 13521
    • Tafenil
    • Tecnoflut
    • Testotard
  • Drug: Goserelin Acetate
    Given via injection
    Other Names:
    • ZDX
    • Zoladex
  • Drug: Leuprolide Acetate
    Given via injection
    Other Names:
    • A-43818
    • Abbott 43818
    • Abbott-43818
    • Carcinil
    • Depo-Eligard
    • Eligard
    • Enanton
    • Enantone
    • Enantone-Gyn
    • Ginecrin
    • LEUP
    • Leuplin
    • Leuprorelin Acetate
    • Lucrin
    • Lucrin Depot
    • Lupron
    • Lupron Depot
    • Lupron Depot-3 Month
    • Lupron Depot-4 Month
    • Lupron Depot-Ped
    • Lutrate
    • Procren
    • Procrin
    • Prostap
    • TAP-144
    • Trenantone
    • Uno-Enantone
    • Viadur
  • Drug: Nilutamide
    Given PO
    Other Names:
    • Anandron
    • Nilandron
    • RU-23908
  • Drug: Prednisone
    Other Names:
    • .delta.1-Cortisone
    • 1, 2-Dehydrocortisone
    • Adasone
    • Cortancyl
    • Dacortin
    • DeCortin
    • Decortisyl
    • Decorton
    • Delta 1-Cortisone
    • Delta-Dome
    • Deltacortene
    • Deltacortisone
    • Deltadehydrocortisone
    • Deltasone
    • Deltison
    • Deltra
    • Econosone
    • Lisacort
    • Meprosona-F
    • Metacortandracin
    • Meticorten
    • Ofisolona
    • Orasone
    • Panafcort
    • Panasol-S
    • Paracort
    • Perrigo Prednisone
    • PRED
    • Predicor
    • Predicorten
    • Prednicen-M
    • Prednicort
    • Prednidib
    • Prednilonga
    • Predniment
    • Prednisone Intensol
    • Prednisonum
    • Prednitone
    • Promifen
    • Rayos
    • Servisone
    • SK-Prednisone
Study Arms  ICMJE
  • Active Comparator: Arm A (finite androgen ablation)
    Participants receive either leuprolide acetate via injection every month or every 4 months, goserelin acetate via injection every month, or degarelix via injection every month for 8 months. Patients also receive bicalutamide PO QD, flutamide PO TID, or nilutamide PO QD. Patients may crossover to Arm B with disease progression after 8 months.
    Interventions:
    • Drug: Bicalutamide
    • Drug: Degarelix
    • Drug: Flutamide
    • Drug: Goserelin Acetate
    • Drug: Leuprolide Acetate
    • Drug: Nilutamide
  • Experimental: Arm B (finite androgen ablation, abiraterone, prednisone)
    Participants receive leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, or nilutamide as in Arm A. Patients also receive abiraterone acetate PO daily for 8 months and prednisone daily. Patients may crossover to Arm A with disease progression after 8 months.
    Interventions:
    • Drug: Abiraterone Acetate
    • Drug: Bicalutamide
    • Drug: Degarelix
    • Drug: Flutamide
    • Drug: Goserelin Acetate
    • Drug: Leuprolide Acetate
    • Drug: Nilutamide
    • Drug: Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2020)		 310
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2013)		 200
Estimated Study Completion Date  ICMJE February 1, 2025
Estimated Primary Completion Date February 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have signed an informed consent document indicating that the subjects understand the purpose of and procedures required for the study and are willing to participate in the study
  • Written Authorization for Use and Release of Health and Research Study Information has been obtained
  • Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
  • Life expectancy >= 12 months
  • ECOG performance status (PS) =< 2
  • Histologically documented diagnosis of adenocarcinoma of the prostate (PCa) with no histologic variants

  • 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 computed tomography (CT) scan

    • After radiation: A rising PSA taken to indicate recurrent prostate cancer in patients with previous definitive external beam radiotherapy will be defined as PSA of 1.0
    • 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
  • 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 6 weeks) prior to starting androgen ablation
  • White blood cell (WBC) >= 3.5 x 10^9/L
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • Platelets >= 100 x 10^9/L
  • Hemoglobin (Hb) >= 9.0 g/dL
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x the upper limit of normal
  • Serum potassium of >= 3.5 mEq/L
  • Serum albumin of >= 3.0 g/dL
  • Serum creatinine =< 1.5 x ULN
  • Patients must have recovered from prior treatment regimens, e.g. surgery, radiation
  • 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
  • Able to swallow the study drug whole as a tablet
  • 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:

  • 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
  • Any known metastases
  • Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (>= 450 msec)
  • 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 II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline
  • Significant co-morbidity that could affect the safety or evaluability of participants as assessed by the treating physician and or principal investigator
  • Prior therapy with strontium-89, samarium, rhenium-186 etidronate, chemotherapy or androgen biosynthesis inhibitors for prostate cancer 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
  • Patients who, in the opinion of the investigator, are unable to comply with the requirements of the study protocol are not eligible
  • Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
  • Active or symptomatic viral hepatitis
  • History of pituitary or adrenal dysfunction
  • Administration of an investigational therapeutic drug within 30 days of cycle 1 day 1
  • Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or their excipients
  • Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
  • Have a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01786265
Other Study ID Numbers  ICMJE 2012-0993
NCI-2018-01856 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2012-0993 ( Other Identifier: M D Anderson Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Logothetis M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP