New drug combo shrinks prostate tumors before radiation

NCT ID NCT02160353

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug combination (abiraterone acetate plus prednisolone and hormone therapy) given before radiation in 45 men with high-risk localized prostate cancer. The goal was to see if the treatment could shrink tumors and lower PSA levels. The approach aims to improve cancer control before definitive radiotherapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

45 people

The number who actually took part.

Started

Jul 2015

Finished

Jan 2021

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cork University Hospital

    Cork, Ireland

  • St Luke's Hospital

    Dublin, 6, Ireland

  • University Hospital Galway

    Galway, Ireland

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