Prostatic Neoplasm Clinical Trial
Official title:
High-Dose-Rate Prostate Brachytherapy Combined With Stereotactic Ablative Prostate Radiotherapy for Patients Diagnosed With Intermediate and High-risk Prostate Cancer. Phase II Clinical Trial.
Dose escalation is nowadays a standard strategy in radiotherapy for prostate cancer. Besides,
it is believed that due to the radiobiology characteristics of prostate cells (low alpha/beta
ratio), the delivery of higher radiation doses per fraction could theoretically improve the
efficacy of the treatment. In this context, the combination of prostate brachytherapy and
external beam radiotherapy (EBRT) has proven to be the most effective method of dose
escalation significantly improving disease control in randomized clinical trials.
Unfortunately, this strategy is also associated with an increased risk of acute and late
adverse events compared to conventional EBRT alone. It has been proposed that this increase
in adverse events could be related to the use Low-Dose-Rate (LDR) brachytherapy and that
High-Dose-Rate (HDR) brachytherapy (a more modern and accurate procedure) could reduce this
risk.
On the other hand, Stereotactic Ablative Radiotherapy (SABR) is a high-precision radiation
technique that allows the delivery of higher doses per fraction in fewer sessions, reducing
the total treatment time.
The investigators hypothesized that the combination of two highly conformal radiation
techniques (HDR brachytherapy and SABR) could be well tolerated, while reducing total
treatment time and therefore improving patient quality of life.
This is a single arm Phase II clinical trial designed to test the feasibility, tolerability
and impact on quality of life of the combination of High-Dose-Rate prostate brachytherapy and
SABR for patients with intermediate and high-risk prostate cancer.
n/a
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