HDR Brachytherapy Plus Stereotactic Ablative Prostate Radiotherapy for Patients With Intermediate and High-risk Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Jul 25, 2023
  • participants needed
    50
  • sponsor
    David Büchser
Updated on 25 January 2021
cancer
stereotactic body radiation therapy
brachytherapy
external beam radiation therapy
adenocarcinoma
adenocarcinoma of prostate

Summary

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.

Details
Condition Malignant neoplasm of prostate, Prostate Cancer, Prostate Cancer, Early, Recurrent, Prostatic disorder, Prostate Disorders, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate tumor, prostate tumors
Treatment Real time High-Dose-Rate prostate brachytherapy in combination with stereotactic prostate radiotherapy
Clinical Study IdentifierNCT04523896
SponsorDavid Büchser
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of adenocarcinoma of the prostate
Intermediate or high-risk disease (as per NCCN criteria)
Intermediate risk
Clinical stage T2c
Gleason score 7 and initial PSA 20 ng/ml
Gleason score 6 and initial PSA > 10 and 20 ng/ml
High risk,at least one of the following
Clinical stage T3a-b
Gleason score 8-10
Initial PSA > 20 ng/ml
Life expectancy of more than 10 years
Able and willing to complete Expanded Prostate Index Composite (EPIC) end EORTC questionnaires
Eastern Cooperative Oncology Group (ECOG) of 0 - 2
Willing to give informed consent to participate in this clinical trial
Give competent informed consent to participate in this trial

Exclusion Criteria

Documented nodal or distant metastases
Previous pelvic radiotherapy
Clinical stage T4
Clinical stage T3a or T3b in which the coverture of the extraprostatic disease is not feasible (as deemed by the treating physician)
Prostate volume > 70 cc (measured on MRI)
Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >17
Contra-indication to radical prostate radiotherapy
Significant medical co-morbidity rendering patient unsuitable for general anaesthetic
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