Neo-adjuvant Abiraterone Prostate Study (NCT02160353) | Clinical Trial Compass
CompletedPhase 2
Neo-adjuvant Abiraterone Prostate Study
Ireland45 participantsStarted 2015-07-09
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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…
What they're measuring
1
Clinical tumour response
Timeframe: 126 days
2
Biochemical response
Timeframe: 126 days
3
Mean percentage reduction in prostate gland volume