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

NCT01717053 | Completed Phase 2 Results

• 1 other identifier: Pro00044071
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (7)

• Time to PSA Nadir

  1 year

• PSA Nadir Value

  1 year, 2 years

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

  36 and 48 months

• Metastasis or Systemic Therapy

  up to 5 years (60 months)

• Testosterone Recovery

  up to 5 years

Study Arms (1)

Abiraterone acetate

EXPERIMENTAL

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

Drug: Abiraterone acetate; Drug: Androgen deprivation; Radiation: Radiation Therapy; Drug: Prednisone

Interventions

Abiraterone acetate DRUG

1000 mg orally once a day for 6 months.

Also known as: Zytiga

Abiraterone acetate

Androgen deprivation DRUG

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).

Abiraterone acetate

Radiation Therapy RADIATION

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

Abiraterone acetate

Prednisone DRUG

5 mg tablet once daily for 6 months.

Abiraterone acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (3)

Durham Regional Hospital

Durham, North Carolina, 27704, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 33259932 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Radiotherapy; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Therapeutics; Pregnadienediols; Pregnadienes; Pregnanes

Results Point of Contact

• Title: Dr. Bridget Koontz
• Organization: Duke University

bridget.koontz@duke.edu

919-668-5213

Study Officials

• Daniel George, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: October 30, 2012
• Study Start: January 17, 2014
• Primary Completion: August 24, 2017
• Study Completion: August 31, 2021
• Last Updated: October 10, 2022
• Results First Posted: September 24, 2018

Record last verified: 2022-10

Locations

US (3)