Does Dutasteride (generic name) cause cancer?

From the Guidelines

Dutasteride does not cause cancer, but rather reduces the overall risk of prostate cancer by 23% as shown in the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial 1. The relationship between dutasteride and prostate cancer is complex, with some studies suggesting a possible association between dutasteride and high-grade prostate cancer. However, this relationship is likely due to detection bias rather than causation, as dutasteride may make high-grade cancers more detectable when they do occur. Key points to consider:

• Dutasteride decreases overall prostate cancer risk, but may increase the detection of high-grade tumors 1.
• The Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial demonstrated a 23% reduction in overall prostate cancer diagnosis with dutasteride compared to control 1.
• Patients taking dutasteride should undergo regular prostate monitoring, including PSA testing, taking into account that dutasteride reduces PSA levels by about 50% 1.
• Men with a family history of prostate cancer should discuss the benefits and risks of dutasteride with their healthcare provider before starting treatment. Some important considerations when interpreting PSA results in patients taking dutasteride include:
• The effect of dutasteride on PSA levels can be variable, with some studies showing a 40% to 60% decrease in PSA after 12 months of treatment 1.
• Failure to achieve a significant PSA decrease while taking 5-ARIs, such as dutasteride, can indicate a heightened risk for prostate cancer that warrants regular testing 1.

From the FDA Drug Label

Dutasteride may increase the risk of high-grade prostate cancer. Higher chance of a more serious form of prostate cancer Dutasteride may increase the risk of high-grade prostate cancer, as stated in the drug label 2 and 2. This is a potential risk that should be considered when taking dutasteride.

• The drug label does not provide a clear causal relationship between dutasteride and cancer.
• However, it does indicate that dutasteride may increase the risk of high-grade prostate cancer.

From the Research

Dutasteride and Cancer Risk

• The relationship between dutasteride and cancer risk is complex, with some studies suggesting a potential increased risk of high-grade prostate cancer 3, 4.
• However, other studies have found that dutasteride may not be associated with an increased risk of prostate cancer, and may even reduce the risk of detection of prostate cancer 4, 5.
• A pooled analysis of 15 real-world databases found that dutasteride was not associated with a lower risk of prostate cancer than finasteride in patients with benign prostatic hyperplasia (BPH) 5.

High-Grade Prostate Cancer Risk

• Some studies have suggested that dutasteride may be associated with an increased risk of high-grade prostate cancer, particularly in the setting of prostate cancer prevention 3, 6.
• However, other studies have found no significant difference in the risk of high-grade prostate cancer between dutasteride and control groups 4.
• The REDUCE trial found that dutasteride reduced the risk of prostate cancer, but also found an increased risk of high-grade tumors 6, 7.

Prostate-Specific Antigen (PSA) and Dutasteride

• Dutasteride has been shown to reduce serum PSA levels, which can make it more difficult to diagnose prostate cancer 6, 7.
• However, some studies have found that PSA can still be a useful marker for prostate cancer in men taking dutasteride, particularly if the PSA level is increasing over time 7.