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Prostate CancerPhase 2NCT01717053

Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer

A Phase 2 study testing Abiraterone acetate, Androgen deprivation and Radiation Therapy in people with Prostate Cancer, run by Duke University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The addition of abiraterone acetate to standard treatment of radiotherapy and short-term androgen deprivation will increase the frequency of undetectable PSA. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Abiraterone acetate, Androgen deprivation and Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
3 sitesUnited States
Study dates
17 Jan 2014to 31 Aug 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • One of the following high risk criteria:
  • Gleason Score 7 with PSA ≤ 20 ng/ml and clinical T1-2, or
  • Gleason Score 8-10, PSA ≤ 20 ng/ml and clinical T1-2a, or
  • PSA 10.1-40 ng/ml with GS < 7 and clinical T1-2, or
  • Clinical T3 with Gleason Score < 7 and PSA ≤ 10 ng/ml.
  • ECOG Performance Status ≤ 1
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  • Digital rectal exam within 90 days of registration on study
  • CBC with differential with adequate bone marrow function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3, Platelets > 100,000/µL and Hemoglobin ≥ 9g/dL
  • Serum potassium ≥ 3.5 mEq/L
  • Serum albumin > 3.0 g/dl
  • Total bilirubin < 1.5 X of institutional upper limit of normal (ULN)
  • AST(SGOT)/ALT(SGPT) < 1.5 X ULN
  • Calculated creatinine clearance > 60 mL/min
  • Age > 18 years
  • Able to swallow a whole tablet and take abiraterone acetate on an empty stomach (defined as no food for two hours before and one hour after abiraterone acetate ingestion)
  • Ability to understand and sign a written informed consent document
  • 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
  • Subjects who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protections as determined acceptable by the principal investigator during the study and for 1 week after the last dose of abiraterone acetate.

Who cannot join

  • Bone, visceral or soft tissue metastasis, including lymph nodes (>2 cm in longest diameter)
  • Prior therapy for prostate cancer [Exceptions: LHRH agonist or antagonist may have been initiated within 30 days prior to enrollment. Bicalutamide may have been given within 60 days of enrollment as long as it has been stopped at least 7 days before enrollment and total duration was no longer than 30 days. This is to allow enrollment of those who have been given bicalutamide as a bridge for LHRH agonist/antagonist. It is highly unlikely a short non-overlapping course of bicalutamide will interact with abiraterone acetate in a measurable way. Previous alpha-reductase inhibitor use allowed IF patient has not been taking for at least 30 days prior to abiraterone acetate initiation, OR if alpha reductase inhibitor was not used as a primary treatment of prostate cancer and the PSA on alpha-reductase inhibitor remains within eligibility when doubled. ]
  • Known serum testosterone ≤ 150 ng/dl or symptoms of hypogonadism (fatigue, hot flashes, hair loss, loss of muscle mass, osteoporosis, low libido, depression) prior to ADT initiation not explained by other medical co-morbidity OR history of testosterone supplement. If questionable, serum testosterone level greater than 150 ng/dl can be used to exclude hypogonadism.
  • Previous malignancy within 3 years other than non-melanomatous skin cancer and non-muscle invasive bladder cancer
  • Previous pelvic radiotherapy that would prevent prostate/SV irradiation
  • Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
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  • History of gastrointestinal disorders that may interfere with the absorption of study drug (including gastric bypass surgery)
  • Concurrent spironolactone use
  • Significant concurrent medical condition that would make prednisone/prednisolone use contraindicated or would interfere with the patient's ability to participate in the trial
  • Receiving any investigational agents currently or within 30 days prior to study screening
  • Prior demonstrated hypersensitivity, intolerance or allergy to abiraterone acetate, prednisone or their excipients
  • Active co-morbidity, defined as follows:
  • Chronic liver disease with cirrhosis (Child-Pugh B or C) or active hepatitis B or C
  • History of pituitary or adrenal dysfunction
  • Poorly controlled diabetes mellitus (A1c >9% or history of complications including peripheral neuropathy, end organ damage, hospitalization, amputation)
  • Poorly controlled glaucoma
  • 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 known cardiac ejection fraction measurement of < 50% at baseline.
  • Clinical evidence of active infection of any type, including active or symptomatic viral hepatitis.
  • Known immune deficiency and/or HIV-positive patients
  • Any medical condition that warrants long-term corticosteroid use in excess of study dose
  • Patients taking strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital)
  • Any condition that in the opinion of the Principal Investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing the study requirements

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Durham Regional Hospital

    Durham, North Carolina, 27704

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase II Trial of Abiraterone Acetate, Radiotherapy and Short-Term Androgen Deprivation in Men With Unfavorable Risk Localized Prostate Cancer

The addition of abiraterone acetate to standard treatment of radiotherapy and short-term androgen deprivation will increase the frequency of undetectable PSA.

Read the detailed description

This is a single arm two-site study of 37 men with unfavorable prostate cancer (defined as having a single high risk factor). Patients will concurrently initiate 6 months of standard-of-care GNRH agonist therapy and once daily abiraterone acetate/prednisone. After 2 months of lead-in hormonal treatment, definitive standard-of-care prostate/seminal vesicle radiotherapy will be delivered, to a total dose of 75-80 Gy.

Conditions
Prostate Cancer
Being tested
Abiraterone acetate, Androgen deprivation, Radiation Therapy, Prednisone
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 Zytiga

    1000 mg orally once a day for 6 months.

  • Androgen deprivationDrug

    LHRH analog (at discretion of treating physician) will be administered over 6 months (for example, leuprolide acetate 22.5mg IM or goserelin acetate 10.8mg SC given every 3 months for 2 doses).

  • Radiation TherapyRadiation

    Daily (Monday-Friday) for 8 weeks, final dose of 75-80 Gy

  • PrednisoneDrug

    5 mg tablet once daily for 6 months.

Study groups in NCT01717053
Study groupRoleWhat they receive
Abiraterone acetateExperimentalAbiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Receives: Drug: Abiraterone acetate; Drug: Androgen deprivation; Radiation: Radiation Therapy; Drug: Prednisone

What is being measured

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

  1. Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year

    The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of <0.1 ng/mL.

    Measured: 1 year

Secondary outcomes (7)

  1. Time to PSA Nadir

    The median time in months to the lowest PSA value from the start of study therapy.

    Measured: 1 year

  2. PSA Nadir Value

    The lowest PSA value from the start of study therapy.

    Measured: 1 year, 2 years

  3. Percentage of Participants With Biochemical Progression-free Survival (BPFS)

    Disease progression defined as Phoenix RTOG definition of nadir PSA + 2ng/ml or initiation of salvage therapy not imaging. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.

    Measured: 36 and 48 months

  4. Metastasis or Systemic Therapy

    Time to either imaging indicating metastasis or beginning a new systemic therapy. This is a distinctly different measure from number 4 above. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.

    Measured: up to 5 years (60 months)

  5. Testosterone Recovery

    Time to testosterone recovery

    Measured: up to 5 years

  6. PSA < 1.5ng/ml in Setting of Non-castrate Testosterone

    Percentage of men with 1, 2, 3, 4 and 5 year PSA < 1.5ng/ml in setting of non-castrate testosterone.

    Measured: 1 year, 2 years, 3 years, 4 years, 5 years

  7. Safety and Tolerability

    The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0.

    Measured: 6 months

Timeline

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

  1. First posted30 Oct 2012 (estimated)
  2. Study start17 Jan 2014
  3. Primary completion24 Aug 2017
  4. Study completion31 Aug 2021

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01717053
Sponsor's protocol ID
Pro00044071
Status last verified
Oct 2022
First submitted
26 Oct 2012
Last updated
10 Oct 2022
Data monitoring committee
No

Publications

  • Koontz BF, Hoffman KE, Halabi S, Healy P, Anand M, George DJ, Harrison MR, Zhang T, Berry WR, Corn PG, Lee WR, Armstrong AJ. Combination of Radiation Therapy and Short-Term Androgen Blockade With Abiraterone Acetate Plus Prednisone for Men With High- and Intermediate-Risk Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1271-1278. doi: 10.1016/j.ijrobp.2020.11.059. Epub 2020 Nov 28.

    PubMed 33259932

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone acetate, Androgen deprivation and Radiation Therapy in people with Prostate Cancer, run by Duke University at 3 sites 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 20 inclusion and 22 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: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 24 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year (time frame: 1 year). 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 NCT01717053, which also lists 1 linked publication.

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 10 Oct 2022.

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