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Prostate AdenocarcinomaPhase 2NCT01786265

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

A Phase 2 study testing Abiraterone Acetate, Bicalutamide and Degarelix in people with Prostate Adenocarcinoma and Recurrent Prostate Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Abiraterone Acetate, Bicalutamide and Degarelix
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
1 siteUnited States
Study dates
5 Feb 2013to 1 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Abiraterone Acetate, Bicalutamide, Degarelix, Flutamide, Goserelin Acetate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone AcetateDrug

    Also called CB7630, Yonsa, Zytiga

    Given PO

  • BicalutamideDrug

    Also called Casodex, Cosudex, ICI 176,334, ICI 176334

    Given PO

  • DegarelixDrug

    Also called FE200486, Firmagon

    Given via injection

  • FlutamideDrug

    Also called 4''-Nitro-3''-trifluoromethylisobutyranilide, Apimid, Cebatrol, Chimax

    Given PO

  • Goserelin AcetateDrug

    Also called ZDX, Zoladex

    Given via injection

  • Leuprolide AcetateDrug

    Also called A-43818, Abbott 43818, Abbott-43818, Carcinil

    Given via injection

  • NilutamideDrug

    Also called Anandron, Nilandron, RU-23908

    Given PO

  • PrednisoneDrug

    Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl

Study groups in NCT01786265
Study groupRoleWhat they receive
Arm A (finite androgen ablation)Active comparatorParticipants 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.
Receives: Drug: Bicalutamide; Drug: Degarelix; Drug: Flutamide; Drug: Goserelin Acetate; Drug: Leuprolide Acetate; Drug: Nilutamide
Arm B (finite androgen ablation, abiraterone, prednisone)ExperimentalParticipants 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.
Receives: Drug: Abiraterone Acetate; Drug: Bicalutamide; Drug: Degarelix; Drug: Flutamide; Drug: Goserelin Acetate; Drug: Leuprolide Acetate; Drug: Nilutamide; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At 12 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2013 (estimated)
  2. Study start5 Feb 2013
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01786265
Sponsor's protocol ID
2012-0993
Other IDs
NCI-2018-01856, 2012-0993
Status last verified
Aug 2026
First submitted
5 Feb 2013
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone Acetate, Bicalutamide and Degarelix in people with Prostate Adenocarcinoma and Recurrent Prostate Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate-specific antigen (PSA) free survival (PSA < 0.1 ng/ml) (time frame: At 12 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01786265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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