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Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer

Primary Purpose

Prostate Adenocarcinoma, Recurrent Prostate Carcinoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Abiraterone Acetate
Bicalutamide
Degarelix
Flutamide
Goserelin Acetate
Leuprolide Acetate
Nilutamide
Prednisone
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A (finite androgen ablation)

Arm B (finite androgen ablation, abiraterone, prednisone)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Prostate-specific antigen (PSA) free survival (PSA < 0.1 ng/ml)

Secondary Outcome Measures

Full Information

First Posted
February 5, 2013
Last Updated
May 25, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01786265
Brief Title
Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 5, 2013 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma, Recurrent Prostate Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (finite androgen ablation)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm B (finite androgen ablation, abiraterone, prednisone)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Abiraterone Acetate
Other Intervention Name(s)
CB7630, Yonsa, Zytiga
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Other Intervention Name(s)
Casodex, Cosudex, ICI 176,334, ICI 176334
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486, Firmagon
Intervention Description
Given via injection
Intervention Type
Drug
Intervention Name(s)
Flutamide
Other Intervention Name(s)
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
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Goserelin Acetate
Other Intervention Name(s)
ZDX, Zoladex
Intervention Description
Given via injection
Intervention Type
Drug
Intervention Name(s)
Leuprolide Acetate
Other Intervention Name(s)
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
Intervention Description
Given via injection
Intervention Type
Drug
Intervention Name(s)
Nilutamide
Other Intervention Name(s)
Anandron, Nilandron, RU-23908
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
.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
Primary Outcome Measure Information:
Title
Prostate-specific antigen (PSA) free survival (PSA < 0.1 ng/ml)
Time Frame
At 12 months after treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Logothetis
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer

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