Clinical trial · Interventional
Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer
Phase II Trial of Radiation With Androgen Deprivation: Abiraterone Acetate, Prednisone and Luteinizing Hormone Releasing Hormone Agonist Prior to Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| abiraterone acetate | Drug | Abiraterone Acetate | ALIAS |
| external beam radiation therapy | Radiation | — | UNRESOLVED |
| goserelin acetate | Drug | Goserelin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| leuprolide acetate | Drug | Leuprolide | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (antihormone therapy and radiation therapy)
- description
- Patients receive abiraterone acetate and prednisone daily for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: abiraterone acetate
- Drug: prednisone
- Drug: leuprolide acetate
- Other: laboratory biomarker analysis
- Radiation: external beam radiation therapy
- Drug: goserelin acetate
Primary outcomes (2)
- measure
- 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
- timeFrame
- Up to 24 months after initiation of radiation therapy
- description
- 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 3.0he distribution of time to late adverse events (observed severities of adverse events over time) will be estimated using the Kaplan-Meier method.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 =\< 2 * Karnofsky \>= 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: =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) \< 2.5 x ULN * Alanine transaminase (ALT) \< 2.5 x ULN * Total bilirubin: =\< 1.5 x ULN (except for patients with documented Gilbert's disease) Exclusion Criteria: * Patients may not be receiving any investigational agents * Concurrent enrollment in another clinical investigational drug or device study is prohibited * The concurrent administration of other anticancer therapy, including cytotoxic or hormonal agents (except Luteinizing hormone releasing hormone agonists), or immunotherapy, is prohibited during neoadjuvant concurrent and adjuvant therapy * Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible * Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible * Patients with hypogonadism or severe androgen deficiency as defined by serum testosterone less than 100 ng/dL will not be eligible * History of pituitary or adrenal dysfunction * Patients who are receiving any androgens, estrogens or progestational agents, or who received any of these agents within the 6 months prior to evaluation will not be eligible * Patients who are taking drugs which affect androgen metabolism (e.g. spironolactone, ketoconazole, finasteride, dutasteride) will not be eligible * Concomitant therapy with any of the following listed is prohibited: 5 alpha-reductase inhibitor (finasteride, dutasteride); ketoconazole, diethylstilbestrol, and other preparations such as saw palmetto thought to have endocrine effects on prostate cancer; radiopharmaceuticals such as strontium (89Sr) or samarium (153Sm); Aldactone, Spironol (spironolactone); estrogens, testosterone, progesterones, herbal medications * Patients who received any of these agents within the 6 months prior to evaluation will be reviewed for eligibility by the Principal Investigator on a case by case basis * Use of other investigational drug therapy for any reason is prohibited * Patients with inflammatory bowel disease or other autoimmune conditions which might affect the radiated colon or rectum * Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia which is symptomatic or requires active therapy, recent deep venous thrombosis, pulmonary emboli, cerebrovascular accident or ischemia will not be eligible * Patients who have chronic active hepatitis or acute hepatitis will not be eligible * Patients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent will not be eligible * Patients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligible * Uncontrolled hypertension within the screening period (systolic blood pressure \[BP\] \>= 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 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
References
Publications (1)
- BACKGROUNDCho E, Mostaghel EA, Russell KJ, Liao JJ, Konodi MA, Kurland BF, Marck BT, Matsumoto AM, Dalkin BL, Montgomery RB. External beam radiation therapy and abiraterone in men with localized prostate cancer: safety and effect on tissue androgens. Int J Radiat Oncol Biol Phys. 2015 Jun 1;92(2):236-43. doi: 10.1016/j.ijrobp.2015.01.020. Epub 2015 Mar 12. PMID 25772183