An open-label phase II study of low-dose thalidomide in androgen-independent prostate cancer
2003

Low-Dose Thalidomide for Prostate Cancer

Sample size: 20 publication 10 minutes Evidence: moderate

Author Information

Author(s): Drake M J, Robson W, Mehta P, Schofield I, Neal D E, Leung H Y

Primary Institution: University of Newcastle

Hypothesis

Can low-dose thalidomide effectively reduce PSA levels in patients with androgen-independent prostate cancer?

Conclusion

Low-dose thalidomide can decrease PSA levels in nearly 40% of patients with androgen-independent prostate adenocarcinoma.

Supporting Evidence

  • Six out of 16 men receiving thalidomide for at least 2 months showed a fall in their serum PSA levels by a mean of 48%.
  • Three of the seven men who completed the full 6-month study showed a fall in absolute PSA by a mean of 50%.
  • Adverse effects included constipation and sedation hangover, but quality of life scores remained stable.

Takeaway

This study tested a low dose of thalidomide to see if it could help men with a type of prostate cancer that doesn't respond to hormones. It worked for some men by lowering a specific cancer marker in their blood.

Methodology

Patients received 100 mg of thalidomide daily for up to 6 months, with monthly assessments of PSA levels and adverse effects.

Potential Biases

Potential bias due to the open-label design and lack of randomization.

Limitations

The study had a small sample size and lacked a control group.

Participant Demographics

Mean age was 71.1 years, with a range of 60 to 83 years; 65% had bony metastases.

Statistical Information

P-Value

0.06

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6600817

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