Phase II study of Enzalutamide with radiation therapy for intermediate risk prostate cancer: A phase 2 study - International Journal of Radiation Oncology, Biology, Physics

Phase II study of Enzalutamide with radiation therapy for intermediate risk prostate cancer: A phase 2 study - International Journal of Radiation Oncology, Biology, Physics

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Phase II study of Enzalutamide with radiation therapy for intermediate risk prostate cancer: A phase 2 study

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Abstract

Background

Androgen deprivation therapy (ADT) is often used as adjuvant treatment with radiation therapy (RT) for intermediate-risk prostate cancer (PCa). ADT is associated with multiple side effects including weight gain, loss of libido and hot flashes. In contrast, anti-androgen monotherapy has been generally better tolerated.

Objective

Assess the effectiveness of enzalutamide (an anti-androgen) monotherapy with RT for the treatment of prostate cancer in intermediate risk prostate..

Method

This trial was an open label phase II study of 6 months of enzalutamide monotherapy with external beam radiation therapy (EBRT) for intermediate risk prostate cancer. Enzalutamide was initiated 2 months prior to EBRT The primary endpoint was PSA response measured at the end of enzalutamide administration at the six month time point. Secondary end-points include assessment of toxicity, changes in anthropomorphic body measurement, sexual function and metabolic changes.

Outcome measurements and statistical analysis

The sample size was calculated to be 64 patients. The null hypothesis was that if ≥ 60% of the patients did not achieve a PSA nadir ≤0.2 ng/ml, the study would be deemed negative.

Results

The results met the pre-specified end point for efficacy in that PSA values ≤0.2 were observed in 49 of 64 (77%) patients, and 60 of 64 (94%) patients had PSA values of at least <0.5ng/ml. The most frequent adverse events were hypertension and gynecomastia. There were no changes in anthropomorphic body measurements and only modest erectile dysfunction..

Conclusion

Using PSA response as an end-point, enzalutamide monotherapymay be as effective as ADT in combination with EBRT for patients with intermediate risk prostate cancer. It is associated with fewer side effects. Randomized trials comparing enzalutamide to ADT are justified.

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Article Info

Publication History

Accepted: February 12, 2021

Received in revised form: February 10, 2021

Received: May 27, 2020

Publication stage

In Press Journal Pre-Proof

Footnotes

Disclosures: None

Funding: Astellos

Statistician : E Werner ewerner@jimmy.harvard.ed ris

Research data are stored in an institutional repository and will be shared upon request to the corresponding author k prostate cancer

Identification

DOI: https://doi.org/10.1016/j.ijrobp.2021.02.027

Copyright

© 2021 Published by Elsevier Inc.

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