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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

This trial does not test a peptide that PepBank tracks.

  • Names Goserelin, does not test it. It appears in the description.
  • Names Leuprolide, does not test it. It appears in the description.

Overview

Status
Completed
Phase
Phase 2
Enrollment
37 participants (actual)
Sponsor
Duke University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
17 Jan 2014
Primary completion
24 Aug 2017
Completion
31 Aug 2021
First posted
30 Oct 2012 (estimated)
Last update posted
10 Oct 2022
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142016201820202022
  1. Ph 2

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

    NCT01717053

    17 Jan 2014 to 31 Aug 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Abiraterone acetateDrug
  • Androgen deprivationDrug
  • Radiation TherapyRadiation
  • PrednisoneDrug

Arms1

  • Experimental

    Abiraterone acetate

    Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 1 year

    Registry description

    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.

Secondary outcomes(7)
  1. Time to PSA Nadir

    Time frame · 1 year

    Registry description

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

  2. PSA Nadir Value

    Time frame · 1 year, 2 years

    Registry description

    The lowest PSA value from the start of study therapy.

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

    Time frame · 36 and 48 months

    Registry description

    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.

  4. Metastasis or Systemic Therapy

    Time frame · up to 5 years (60 months)

    Registry description

    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.

  5. Testosterone Recovery

    Time frame · up to 5 years

    Registry description

    Time to testosterone recovery

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

    Time frame · 1 year, 2 years, 3 years, 4 years, 5 years

    Registry description

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

  7. Safety and Tolerability

    Time frame · 6 months

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 1 year

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

GroupValue (percentage of participants)
Abiraterone+Radiotherapy+ADT54.54
Secondary and other outcome results(7)
Secondary outcomeMedian· 1 year

Time to PSA Nadir

GroupValue (months)
Abiraterone+Radiotherapy+ADT8.9
Secondary outcomeMedian· 1 year, 2 years

PSA Nadir Value

GroupValue (ng/mL)
Abiraterone+Radiotherapy+ADT0.03
Secondary outcomeNumber· 36 and 48 months

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

GroupValue (percentage of participants)
Abiraterone Acetate96.96
Secondary outcomeMean· up to 5 years (60 months)

Metastasis or Systemic Therapy

GroupValue (months)
Abiraterone Acetate60
Secondary outcomeMedian· up to 5 years

Testosterone Recovery

GroupValue (months)
Abiraterone Acetate9.2
Secondary outcomeNumber· 1 year, 2 years, 3 years, 4 years, 5 years

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

GroupValue (percentage of patients)
Abiraterone+Radiotherapy+ADT100
Secondary outcomeCount of participants· 6 months

Safety and Tolerability

GroupValue (Participants)
Abiraterone+Radiotherapy+ADT12

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Abiraterone+Radiotherapy+ADTAbiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.0 / 374 / 3736 / 37

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedKoontz 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. PMID 33259932

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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 * 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

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