Prostate Cancer Clinical Trial
— HITMAN-PCOfficial title:
A Phase I/II Study of Hydroxychloroquine and Itraconazole as Therapy for Men With Androgen Normalised Prostate Cancer
Verified date | November 2023 |
Source | St Vincent's Hospital, Sydney |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Recent pre-clinical work has suggested that Itraconazole has an anti-cancer effect that works synergistically with hydroxychloroquine. This may delay the need for androgen deprivation therapy (ADT) and its associated toxicities in men with biochemically recurrent (BCR) prostate cancer. This study aims to determine feasibility, safety and efficacy of suba-itraconazole (SI) in combination with hydroxychloroquine (HQ) in the treatment of biochemically recurrent (BCR) prostate cancer as means of delaying time to commencement of androgen deprivation therapy.
Status | Completed |
Enrollment | 12 |
Est. completion date | October 30, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Males = 18 years of age with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features 2. Prostate cancer initially treated by radical prostatectomy, radiotherapy (including brachytherapy) or both, with curative intent 3. PSA = 1 ng/ml with at least two sequential rises at least 1 week apart according to PCWG3. 4. Serum testosterone = 5 nmol/L 5. QTc = 470 msec using Fridericia correction formula 6. Adequate bone marrow function with platelets = 100 x 10^9/L, ANC = 1.5 x 10^9/L, Hb = 100 g/L in the absence of transfusion 7. Adequate liver function with ALT/AST < 1.5 x ULN, bilirubin < 1.5 x ULN 8. Adequate renal function with creatinine clearance > 50 ml/min 9. ECOG Performance Status = 1 10. Able to start study treatment within 28 days of consent 11. Willing and able to comply with all study requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments 12. Signed, written informed consent Exclusion Criteria: 1. Contraindications to investigational product including hypersensitivity, treatment with any CYP3A4 inducer or inhibitor or known G6PD deficiency. If on a statin, must be changed to rosuvastatin or ceased, as appropriate 2. Evidence of metastatic disease on conventional WBBS or CT. However low volume regional nodes (= N1, up to the aortic bifurcation) may be accepted in asymptomatic patients. 3. PSA doubling time = 3 months calculated using MSKCC calculator (https://www.mskcc.org/nomograms//prostate/psa-doubling-time) 4. Prior systemic therapy for advanced cancer prostate cancer such as hormonal therapy or chemotherapy; neo/adjuvant hormonal therapy allowed if = 24 months total duration and ceased = 12 months prior to enrolment 5. Life expectancy of = 1 year 6. History of another invasive cancer within 3 years before screening with the exception of fully treated cancer with remote probability of recurrence 7. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety 8. Use of hydroxychloroquine and/or itraconazole for any indication in the preceding 2 years or at any time for treatment of prostate cancer. 8. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol. 9. Men must have been surgically sterilised or use a barrier method of contraception. 10. Pre-existing retinopathy, keratopathy or other ocular pathologies that, in the opinion of an ophthalmologist would put the patient at risk of hydroxychloroquine induced retinopathy 11. History of cardiac failure or recent history if ischaemic heart disease (<2 years) |
Country | Name | City | State |
---|---|---|---|
Australia | St Vincent's Hospital | Darlinghurst | New South Wales |
Lead Sponsor | Collaborator |
---|---|
St Vincent's Hospital, Sydney |
Australia,
Farrow JM, Yang JC, Evans CP. Autophagy as a modulator and target in prostate cancer. Nat Rev Urol. 2014 Sep;11(9):508-16. doi: 10.1038/nrurol.2014.196. Epub 2014 Aug 19. — View Citation
Suzman DL, Antonarakis ES. High-dose itraconazole as a noncastrating therapy for a patient with biochemically recurrent prostate cancer. Clin Genitourin Cancer. 2014 Apr;12(2):e51-3. doi: 10.1016/j.clgc.2013.11.015. Epub 2013 Nov 14. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of Recommended Phase II Dose of Hydroxychloroquine in combination with Suba-itraconazole | Recommended Phase II Dose | 6 months | |
Secondary | PSA response rate | Fall in PSA >/=50% from baseline | 1 year | |
Secondary | Composite safety | Rate of adverse events defined by CTCAE criteria | 1 year | |
Secondary | Time to ADT commencement | Time to start of ADT | 1 year | |
Secondary | Metastasis-free survival | Time from commencement of treatment to first metastatic lesion on CT or WBBS | 1 year |
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