Phase II pre-operative study of Androgen Deprivation Therapy (Degarelix) and Erdafitinib in high-risk localized prostate cancer.

Phase 2

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12618001061224
• Lead Sponsor: Melbourne Health (The Royal Melbourne Hospital)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-26
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: Male
• Target Recruitment: 9

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.

ECOG 0-1

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

History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug.

Hypogonadism or severe androgen deficiency as defined by serum testosterone less than 100 ng/dL

Study & Design

• Study Type: Interventional
• Study Design: Not specified