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The meta-analysis is the first-of-its-kind phase 3 randomized clinical trial with individual patient data.
In a first-of-its kind meta-analysis, published in The Lancet Oncology, investigators from Case Western Reserve University and University Hospitals (UH) show that there is consistent improvement in overall survival in men with high- and intermediate-risk prostate cancer with the addition of hormone therapy to radiotherapy treatments.
Throughout the past 40 years, randomized trials have been conducted on the impact of adding hormone therapy to prostate cancer treatments. Although these trials individually show the benefit of hormone therapy, there are inconsistencies in the duration and timing of treatment recommendations.
“Our research team set out to conduct a first-of-its-kind, comprehensive analysis by collecting individual patient data from each and every randomized trial conducted around the world and performed a meta-analysis of the impact of various treatment intensification strategies using hormone therapy with radiation therapy for localized prostate cancer,” Daniel Spratt, MD, Vincent K. Smith chair in radiation oncology at UH Seidman Cancer Center, said in a statement.“Our goal is to better personalize therapy for prostate cancer patients, by providing the most precise and accurate estimates of the benefit of hormone therapy.”.
The investigators made 3 key discoveries during the analysis.
First, men with high- and intermediate-risk prostate cancer have an increased survival rate from the addition of hormone therapy to radiotherapy. This was seen in both older and younger men, as well as those treated with higher and lower doses of radiotherapy.
Investigators also found that the survival rate in men with prostate cancer improves with the prolongation of adjuvant hormone therapy to radiotherapy. The benefit was seen in individuals treated with higher and lower doses of radiotherapy, older and younger men, , and those with both high- and intermediate-risk prostate cancer. Prior to this analysis, no trial was large enough to show a clear benefit in intermediate-risk disease from extending the duration of adjuvant hormone therapy.
Finally, investigators found that the prolongation of neoadjuvant hormone therapy before radiotherapy did not benefit men in any outcomes measured. Some countries routinely give extended durations of hormone therapy before radiotherapy, but investigators found that this method is not advantageous over shorter durations.
The Meta-Analysis of Randomized Trials in Cancer of the Prostate (MARCAP) Consortium is the first, comprehensive, international collaboration of a phase 3 randomized clinical trial with individual patient data.
The ability to analyze data from every clinical trial group in the world, investigating the impact of hormone therapy with radiotherapy, demonstrated immense progress in the prostate oncology field.
In the analysis, 12 randomized trials were included. However, investigators have increased that number to more than 20 trials and continue to add from groups around the world that have agreed to share data.
The next step in the research will be a repository used to investigate additional clinically relevant questions regarding extending studies into the advanced and recurrent disease states, fractionation, optimal dosing of radio therapy, and use of pelvic nodal radiotherapy.
Reference
Researchers show increased survival rate in prostate cancer patients with addition of hormone therapy treatments. EurekAlert. News release. January 18, 2022. Accessed January 20, 2022. https://www.eurekalert.org/news-releases/940306