A small trial but if ADT fails perhaps something to look into.

clinicaltrials.gov/ct2/show...

[Spyder54]

RSH,Re: Itraconozole.

I read through it, saw the 2 goals of study: % of men w 25% or less PSA Advance at 6 mos, and secondarily men w a 50% reduction in PSA. 2 groups: 200mg 1x/day, or 300mg 2x/day=600mg.

BUT…I do not see results? Is that because study is ongoing?

I see John Hopkins & MSK running it.

Thanks,

Mike

[Hidden in reply to Spyder54]

It's a small study and wasn't placebo-controlled. I'm not sure how much stock I would put in this tiny study. But if I had metastatic CRPC I'd at least look into it.

Results of high dose vs. low dose:

To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy With One of Two Dose-levels of Itraconazole: 200 mg or 600 mg Daily.

Low dose 12%

High dose 48%

To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.

Low dose 0%

High dose 14%

[Spyder54 in reply to Hidden]

Thanks RSH,Didn’t read it as result. Something anyway. Side effects similar to ADT. Strange about Anorexia ? I think of that more as a body image issue rather than hunger disorder.

Mike

[LearnAll]

Ketoconazole..sister of Itraconzole has been used in the past to block CYP.17 enzymes. These -Zoles are anti fungal medicines but they do what Zytiga does..block the enzyme needed for T synthesis.

[cesces]

From wikipedia:

"In the past decade, itraconazole has been explored as an anticancer agent for patients with basal cell carcinoma, non-small cell lung cancer, and prostate cancer.[11]

For example, in a phase II study involving men with advanced prostate cancer, high-dose itraconazole (600 mg/day) was associated with significant PSA responses and a delay in tumor progression.

Itraconazole also showed activity in a phase II trial in men with non-small cell lung cancer when it was combined with the chemotherapy agent, pemetrexed.[12][13][14] A recent review has also highlights its use topically and orally in conjunction with other chemotherapeutic agents for advanced and metastatic basal cell carcinomas that cannot be treated surgically.[15]"

[Graham49]

In the study details it says " Itraconazole has been shown in cellular and animal models to be a potent angiogenesis inhibitor as well as a Hedgehog pathway antagonist; both pathways are considered important in prostate cancer. "

Why no phase 3 study? Perhaps lack of a sponsor. It would not be a big earner for the drug company!

[MateoBeach]

Itraconazole does not appear to work by the same pathway as ketaconazole. Hedgehog signaling vs CYP17a inhibition. It does not lower testosterone levels as I recall. It might be a useful adjunct with minimal risk in APC. But it is off patent now (previously marketed for toenail fungus as Sporanox) so no money to finance a Phase 3 trial. Hard to source even though generic