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Itraconazole as a Noncastrating Treatment for Biochemically Recurrent Prostate Cancer: A Phase 2 Study
Mina Lee1, Haemin Hong1, Won Kim1
1University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA.
Background:
Patients with biochemically recurrent prostate cancer and short prostate-specific antigen doubling time (PSADT) are at risk for metastasis yet may wish to avoid androgen deprivation therapy. Itraconazole may have antitumor activity without affecting circulating androgen levels. We therefore evaluated itraconazole as a potentially noncastrating treatment approach in biochemically recurrent prostate cancer.
Patients And Methods:
Patients with biochemically recurrent prostate cancer and PSADT ≤ 15 months, with serum testosterone > 150 ng/dL, were prospectively enrolled. The primary end point was the proportion of patients who experienced ≥ 50% decline from baseline in serum prostate-specific antigen (PSA) by week 12.
Results:
Twenty-one patients were enrolled. The median (range) age, baseline PSA, and PSADT at study entry was 72 (49-76) years, 7.6 (1.5-45.5) ng/mL, and 5.7 (1.2-13.0) months, respectively. Among 19 patients with evaluable data, 1 patient (5%) had a > 50% PSA decline. Nine patients (47%) experienced any PSA decline (mean decline 25.0%, range 2%-60%) by week 12. Among 10 patients without a PSA decline, the on-treatment versus pretreatment PSADT was not significantly longer (median 6.8 vs. 4.3 months, P = .17). There was no significant change from baseline to week 12 in serum testosterone (median change = 32.4%, P = .21) or androstenedione (median change = -8.3%, P = .85). The most common adverse events were edema (52%), fatigue (38%), hypertension (24%), and hypokalemia (24%).
Conclusion:
Itraconazole modulates serum PSA levels without lowering serum testosterone. However, the magnitude of effect is modest, and treatment carries risk of toxicities associated with mineralocorticoid excess.
Insights
Itraconazole showed modest effects on prostate-specific antigen (PSA) levels in recurrent prostate cancer patients without lowering testosterone. However, benefits were limited, and side effects like edema and fatigue were common.
Area of Science:
- Oncology
- Pharmacology
Background:
- Biochemically recurrent prostate cancer poses metastasis risk, with patients often seeking alternatives to androgen deprivation therapy.
- Itraconazole, an antifungal, exhibits potential antitumor activity independent of androgen levels.
- This study investigated itraconazole as a non-castrating treatment for recurrent prostate cancer.
Purpose of the Study:
- To evaluate the efficacy of itraconazole in patients with biochemically recurrent prostate cancer and a short prostate-specific antigen doubling time (PSADT).
- To assess itraconazole's impact on serum prostate-specific antigen (PSA) levels as a primary endpoint.
- To determine if itraconazole can modulate PSA without significantly affecting circulating testosterone levels.
Main Methods:
- Prospective enrollment of patients with biochemically recurrent prostate cancer and PSADT ≤ 15 months, serum testosterone > 150 ng/dL.
- Primary endpoint: proportion of patients achieving ≥ 50% decline in serum PSA by week 12.
- Monitoring of serum testosterone and androstenedione levels, and adverse events.
Main Results:
- One out of 19 evaluable patients (5%) achieved a >50% PSA decline; 47% experienced any PSA decline (mean 25%).
- No significant change in PSADT was observed in patients without PSA decline.
- No significant changes in serum testosterone or androstenedione levels were noted; common adverse events included edema, fatigue, hypertension, and hypokalemia.
Conclusions:
- Itraconazole can modulate serum PSA levels in recurrent prostate cancer without reducing testosterone.
- The observed PSA reduction was modest, indicating limited clinical efficacy.
- Treatment with itraconazole carries risks of toxicities, particularly those related to mineralocorticoid excess.
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