Phase 2
Completed N=24
Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer
Prostate Cancer · Stage II Prostate Cancer · Stage III Prostate Cancer · Stage IV Prostate Cancer
Source: ClinicalTrials.gov NCT01023061 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 — 6 Participants — p=< 0.01
Summary
This phase II trial studies the side effects and how well abiraterone acetate, prednisone, and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and leuprolide acetate or goserelin before or together with radiation therapy may be an effective treatment for prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 |
6 | < 0.01 sig |
| PRIMARY Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry |
0.050 | — |
| SECONDARY Median Time to Prostate Specific Antigen Progression |
5 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide written informed consent
- Patients must allow biopsy prior to neoadjuvant therapy and at the time of fiducial placement
- Written Authorization for Use and Release of Health and Research Study Information has been obtained
- Histologically proven adenocarcinoma of the prostate
- Patients must be candidates for short or long term androgen deprivation in combination with external beam radiotherapy (RT) based on the following criteria:
- Intermediate Risk Disease: T2b/c, or Gleason 7, or Prostate Specific Antigen 10-20
- High Risk Disease: Gleason 8-10, or Prostate specific antigen> 20, or T3/4
- Patients may not have received any prior pharmacologic therapy or radiation therapy (RT) for prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status = = 60%
- Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the androgen axis will be determined following review of their case by the Principal Investigator
- White blood cell count: >= 3,000/mm^3
- Absolute granulocyte count: >= 1,000/mm^3
- Platelets: >= 100,000/mm^3
- Hemoglobin >= 10g/dL
- Potassium >= 3.5 mmol/L
- Serum creatinine: = = 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 congestive heart failure of any severity
- Other active malignancy, except non-melanoma skin cancer and superficial bladder cancer
- History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
- Patients with diabetes not controlled with diet alone (i.e. requiring insulin or oral hypoglycemics)
- Patients unwilling to use contraceptives while on study
Data sourced from ClinicalTrials.gov (NCT01023061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.