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High Risk Localised Prostate CarcinomaPhase 2NCT02160353

Neo-adjuvant Abiraterone Prostate Study

A Phase 2 study testing Abiraterone acetate, Prednisolone in people with High Risk Localised Prostate Carcinoma, run by Cancer Trials Ireland at 3 sites in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
High Risk Localised Prostate Carcinoma
What is being tested?
Abiraterone acetate, Prednisolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
3 sitesIreland
Study dates
9 Jul 2015to 19 Jan 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

Ireland3 sites

  • Cork University Hospital

    Cork

  • St Luke's Hospital

    Dublin, 6

  • University Hospital Galway

    Galway

Other trials in Ireland

About this study

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

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.

Being tested
Abiraterone acetate, Prednisolone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone acetate, PrednisoloneDrug

Study groups in NCT02160353
Study groupRoleWhat they receive
Combined hormonal therapyExperimentalAbiraterone 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)
Receives: Drug: Abiraterone acetate, Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical tumour response

    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)

    Measured: 126 days

  2. Biochemical response

    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)

    Measured: 126 days

  3. Mean percentage reduction in prostate gland volume

    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)

    Measured: 126 days

Secondary outcomes (1)

  1. Testosterone level

    To report the decrease in testosterone level

    Measured: 126 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2014 (estimated)
  2. Study start9 Jul 2015
  3. Primary completion19 Jan 2021
  4. Study completion19 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02160353
Sponsor's protocol ID
CTRIAL-IE (ICORG) 13-23
Status last verified
Apr 2026
First submitted
4 Jun 2014
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone acetate, Prednisolone in people with High Risk Localised Prostate Carcinoma, run by Cancer Trials Ireland at 3 sites in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical tumour response (time frame: 126 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02160353.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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