ACTRN12618001061224
Terminated
Phase 2
ADEPT: Phase II neo-adjuvant study of Androgen Deprivation Therapy (Degarelix) and Erdafitinib in high-risk localized prostate cancer.
Melbourne Health (The Royal Melbourne Hospital)0 sites9 target enrollmentJune 26, 2018
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Melbourne Health (The Royal Melbourne Hospital)
- Enrollment
- 9
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed prostate cancer, present in at least 2 biopsy cores, associated with one of the following features: PSA \>20 ng/ml, predominant cancer Gleason pattern 4 or above (Gleason 4\+3\=7, 8\-10\), clinical stage \>/\= T2c.
- •Otherwise suitable for radical prostatectomy with curative intent.
- •Normal organ and marrow function.
Exclusion Criteria
- •The presence of bony metastatic disease.
- •Prior systemic therapy for prostate cancer.
- •Previous local therapy for prostate cancer including prior external beam radiotherapy, brachytherapy, HIFU or cryotherapy.
- •Active hepatitis B or C infection
- •Known active AIDS (human immunodeficiency virus (HIV) infection) unless the subject has been on a stable anti\-retroviral therapy regimen for the last 6 months or more, has had no opportunistic infections in the last 6 months, and has CD4 count \>350
- •History or current evidence of endocrine alteration of calcium\-phosphorus homeostasis
- •History or current evidence of calcification/mineralisation of soft tissue or internal organs, with the exception of lymph node calcification or asymptomatic arterial calcification.
- •History or current evidence of corneal disorder/keratopathy or retinal abnormality, confirmed by ophthalmologic examination.
- •Uncontrolled hypertension
- •Clinically significant cardiac disease
Outcomes
Primary Outcomes
Not specified
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