Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Anti-Inflammatory Agents

Reproductive Control Agents

Androgens

Abiraterone Acetate

Prednisone

Leuprolide

Goserelin

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

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

Abiraterone acetate

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).

Androgen deprivation

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

Radiation Therapy

Daniel George, MD

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

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.

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

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

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.

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

The lowest PSA value from the start of study therapy.

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.

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.

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

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.

Janssen Pharmaceuticals

Duke University

Abiraterone+Radiotherapy+ADT

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Bridget Koontz

This analysis includes all patients that completed protocol therapy.

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

Time to PSA Nadir

Year 1

Year 2

PSA Nadir Value

36 months

48 months

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

Abiraterone acetate: 1000 mg orally once a day for 6 months.

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

Prednisone: 5 mg tablet once daily for 6 months.

Men with unfavorable prostate cancer (defined as having a single high risk factor)

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

Men with unfavorable prostate cancer (defined ad having a single high risk factor)

Spots Global Cancer Trial Database for Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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