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Neo-adjuvant Abiraterone Prostate Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02160353
Recruitment Status : Active, not recruiting
First Posted : June 10, 2014
Last Update Posted : July 28, 2020
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Cancer Trials Ireland

Brief Summary:
The role of this study is to focus on the potential role of abiraterone acetate in treatment-naive patients newly diagnosed with high-risk localised prostate cancer requiring combined hormonal therapy and radiotherapy.

Condition or disease Intervention/treatment Phase
High Risk Localised Prostate Carcinoma Drug: Abiraterone acetate, Prednisolone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Single-arm Study Evaluating Neo-adjuvant (Pre-radical Radiotherapy) Abiraterone Acetate (Plus Prednisolone) and Gonadotropin-Releasing Hormone (GnRH) Agonist in High Risk Localised Prostate Carcinoma
Actual Study Start Date : May 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Experimental: Combined hormonal therapy
Abiraterone acetate: 1000mg/day (four 250g tablets, orally once a day) for 126 days Prednisolone; 5mg/day (1 tablet orally once a day, concomitant to abiraterone acetate) for 126 days GnRh agonist for 4 injections (at 28 day intervals)
Drug: Abiraterone acetate, Prednisolone



Primary Outcome Measures :
  1. Clinical tumour response [ Time Frame: 126 days ]
    To evaluate the clinical tumour response achieved by 126 days of neo-adjuvant combined treatment by abiraterone acetate, prednisolone and GnRH agonist in treatment of naive high-risk localised prostate carcinoma patients (prior to radical radiotherapy)

  2. Biochemical response [ Time Frame: 126 days ]
    To evaluate biochemical response achieved by 126 days of neo-adjuvant combined treatment by abiraterone acetate, prednisolone and GnRH agonist - in treatment naive high-risk localised prostate carcinoma patients (prior to radical radiotherapy)

  3. Mean percentage reduction in prostate gland volume [ Time Frame: 126 days ]
    To evaluate the mean percentage reduction in prostate gland volume achieved by 126 days of neo-adjuvant combined treatment by abiraterone acetate, prednisolone and GnRH agonist - in treatment naive high-risk localised prostate carcinoma patients (prior to radical radiotherapy)


Secondary Outcome Measures :
  1. Testosterone level [ Time Frame: 126 days ]
    To report the decrease in testosterone level



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent prior to any study related procedures
  • Males aged 18 years or older
  • ECOG performance status of less than or equal to 1
  • Life expectancy of 10 years or more (using MSKCC nomogram)
  • Pathological proven prostate carcinoma at intermediate to high risk of recurrence as defined by RTOG
  • Clinically negative lymph nodes as established by imaging (pelvic CT / MRI), nodal sampling, or dissection within 60 days prior to registration, except patients with lymph nodes equivocal or questionable by imaging are eligible without biopsy if the nodes are less than or equal to 1.5cm; any node larger than this ion imaging will require negative biopsy for eligibility
  • No evidence of bone metastases on bone scan within 60 days prior to registration. Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis.
  • Clinical laboratory values during screening:

    • Haemoglobin greater than or equal to 10.0g/dl
    • Absolute neutrophil count (ANC) ≥ 1.8 × 10 to the power of 9/L
    • Platelets ≥ 100 × 10 to the power of 9/L
  • Systolic blood pressure < 160 mmHg and diastolic blood pressure < 95 mmHg [Note: medically controlled hypertension is permitted]
  • Prostate gland size measurable by trans-rectal ultrasound (TRUS) and at least greater than or equal to 30 cm cubed at baseline
  • Patient is willing to use barrier-method of contraception along with another effective contraceptive method if engaged in sexual activity with a pregnant woman or a woman of child-bearing potential (until 1 week after completing treatment)

Exclusion Criteria:

  • Prior treatment for prostate carcinoma, including prostatectomy; high intensity focused ultrasound or cryotherapy; hormonal manipulation (any modalities) including LHRH agonist, anti-androgen, or bilateral orchidectomy; prior or concomitant chemotherapy for prostate cancer; prior radiotherapy including brachytherapy to the region of study cancer; radical local treatment [Exception: Transuretheral Resection of the Prostate (TRUP) / TRUS is allowed]
  • Use of urethral catheter
  • History of cardiovascular disease; Uncontrolled hypertension [hypertension controlled by anti-hypertensive therapy is permitted], 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 Class III or IV heart failure, or Class II to IV heart failure of cardiac ejection fraction measurement of <50%
  • Active or symptomatic viral hepatitis or chronic liver disease
  • Major thoracic or abdominal surgery or significant traumatic injury within 4 weeks prior to registration, or planned surgery during study participation / within 4 weeks from end of treatment [Note: patients with planned surgical procedures to be conducted under local anaesthesia are not excluded from the study]
  • Gastrointestinal disorder interfering with study drug absorption
  • Active or uncontrolled disease that may require oral corticosteroid therapy
  • Positive serology for hepatitis B surface antigen or hepatitis C antibody
  • Known allergies, hypersensitivity or intolerance to abiraterone acetate, prednisolone, GnRH agonists or their excipients
  • Contraindications to the use of prednisolone or GnRH agonists per local prescribing information
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
  • Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or that could prevent, limit, or confound the protocol-specified assessments
  • The patient has or had othe co-existing malignancies within the past 5 years, other than resected non-melanoma skin cancer
  • Treatment with non-approved or investigational drug within 30 days before the first planned dose of study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160353


Locations
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Ireland
Cork University Hospital
Cork, Ireland
St Luke's Hospital
Dublin, Ireland, 6
University Hospital Galway
Galway, Ireland
Sponsors and Collaborators
Cancer Trials Ireland
Janssen, LP
Investigators
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Principal Investigator: Pierre Thirion, Dr St Luke's Radiation Oncology Network, St Luke's Hospital
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Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT02160353    
Other Study ID Numbers: CTRIAL-IE (ICORG) 13-23
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Prednisolone
Abiraterone Acetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors