Research / Trials currently seeking applicants
All the following studies involve an initial visit called a ‘screening visit’. At this visit a Patient Information Sheet and Consent Form is discussed and signed to confirm participation in the study. Once this form has been signed further information will be gathered from the patient to ensure they meet the inclusion criteria.
A Multicenter, Randomized, Double-Blind, Phase III study of ARN-509 in Men with Non-Metastatic Castration-Resistant Prostate Cancer.
- Histologically or cytologically confirmed CA prostate with PSADT ≤ 10 months
- Castration-resistant demonstrated during continuous androgen deprivation therapy (ADT)/post orchiectomy, defined as 3 consecutive rises of PSA, 1 week apart, resulting in two 50% increases over the nadir, with the last PSA > 2 ng/mL
- Maintain castrate levels of testosterone (< 50 ng/dL [1.72 nmol/L]) throughout the study
- Patients currently receiving bone loss prevention treatment with bone-sparing agents (e.g., bisphosphonates, denosumab [Prolia®]) must be on stable doses for at least 4 weeks prior to randomization
- Patients who received a first generation anti-androgen (e.g., bicalutamide, flutamide, nilutamide) must show continuing disease (PSA) progression off the anti-androgen for at least 4 weeks.
- At least 4 weeks must have elapsed from the use of 5-α reductase inhibitors (e.g., dutasteride, finasteride, aminoglutethamide), estrogens, and any other anti-cancer therapy, including chemotherapy given in the adjuvant/neoadjuvant setting (e.g., clinical trial)
- At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Study Period: 2014-2016
Patient commitment: 1 year, clinic visit monthly
ONC-MA-1001 Observational Study
Prospective, Longitudinal, Mulitinational, Observational Study to Describe Patterns of Care & Outcomes of Men Who Are at High Risk For Poor Clinical Outcomes After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men with CRPC & Men with mPC at Initial Diagnosis.
- Diagnosis of prostate cancer
- Receiving treatment for PC at time of study entry as defined by 1 of the following:
- Biochemical Failure (following Radical- Prostatectomy PSA ˃0.2 or following Radiotherapy)
- Newly diagnosed CRPC
- mPC at initial diagnosis & will receive active systemic therapy.
Study Period: 2013-2016
Patient commitment: Initial clinic visit then follow up phone call at subsequent treatments.
RELIEF II Study
A Prospective, Non-Randomised, Multi-Center Clinical Investigation of the Safety and Performance of GT Urological, LLC’s Phenix Device Artificial Urinary Sphincter
- Has had a radical prostatectomy, transurethral resection of the prostate (TURP) or other prostate surgery more than six months ago
- Has stress urinary incontinence
- Has a normal PSA
- Is willing and able to comply with study requirements
Study period: 2015 – 2018
Patient commitment: 14 months, 9 clinic visits including surgery
If you are interested in participating in a urological study, please contact Urology Bay of Plenty’s Research Manager, Rana Reuther, on 07 577 7795 or email firstname.lastname@example.org.