None listed
Conditions
Brief summary
This is an open label phase II trial of a combination of therapies targeting prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have confirmed prostate cancer which is suitable for radical prostatectomy with curative intent. Study details All participants in this trial will be treated with two medications called Degarelix and Erdafitinib for a period of 3 months, followed by Degarelix alone for a further 1-month prior to radical prostatectomy. Participants will be assessed at regular intervals in order to determine the safety, tolerability and response rate to treatment when compared with historically treated patients. Assessments include blood tests, eye examinations, heart examinations and vital signs. We cannot guarantee or promise that participants will receive any benefits from this research; however, possible benefits may include further knowledge for treatment options for patients in the future with high risk prostate cancer.
Interventions
This is an open label phase II trial in the neo-adjuvant setting. After signing informed consent, patients will be treated with combination Degarelix 240/80 mg subcutaneously plus Erdafitinib 8 mg orally.. A starting dose of 240 mg of Degarelix is administered as two consecutive subcutaneous injections of 120 mg each, a maintenance dose of 80 mg is administered as one subcutaneous injection for each following month. An initial dose of 8 mg of Erdafitinib is taken orally daily with subsequent up
This is an open label phase II trial in the neo-adjuvant setting. After signing informed consent, patients will be treated with combination Degarelix 240/80 mg subcutaneously plus Erdafitinib 8 mg orally.. A starting dose of 240 mg of Degarelix is administered as two consecutive subcutaneous injections of 120 mg each, a maintenance dose of 80 mg is administered as one subcutaneous injection for each following month. An initial dose of 8 mg of Erdafitinib is taken orally daily with subsequent up-titration based on serum phosphate levels. Combined Erdafitinib plus Degarelix is given for 3 months, followed by Degarelix alone, for a further 1 month prior to radical prostatectomy. Compliance will be monitored by counting the Erdafitinib capsules at each visit, this will be logged on the drug accountability sheet and signed by the Principal Investigator. Participants will have regular blood tests to keep an eye on any possible side effects from these medications.
Sponsors
Melbourne Health (The Royal Melbourne Hospital)
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed