PSMA-PET/MRI-Based Focal Dose Escalation in Patients with Primary Prostate Cancer Treated with Stereotactic Body Radiation Therapy (HypoFocal-SBRT): Study Protocol of a Randomized, Multicentric Phase III Trial
Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time, and by (ii) enabling safe delivery of high RT doses. Several studies proposed a dose–response relationship f...
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oai:doaj.org-article:61b329409a6840e38e51365c8dece7862021-11-25T17:04:05ZPSMA-PET/MRI-Based Focal Dose Escalation in Patients with Primary Prostate Cancer Treated with Stereotactic Body Radiation Therapy (HypoFocal-SBRT): Study Protocol of a Randomized, Multicentric Phase III Trial10.3390/cancers132257952072-6694https://doaj.org/article/61b329409a6840e38e51365c8dece7862021-11-01T00:00:00Zhttps://www.mdpi.com/2072-6694/13/22/5795https://doaj.org/toc/2072-6694Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time, and by (ii) enabling safe delivery of high RT doses. Several studies proposed a dose–response relationship for patients with primary PCa and especially in patients with high-risk features, as dose escalation leads to improved tumor control. In parallel to the improvements in RT techniques, diagnostic imaging techniques like multiparametric magnetic resonance imaging (mpMRI) and positron-emission tomography targeting prostate-specific-membrane antigen (PSMA-PET) evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time. The HypoFocal-SBRT study combines ultra-hypofractionated RT/stereotactic body RT, with focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. This novel strategy will be compared with moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. We suspect an increase in relapse-free survival (RFS), and we will assess quality of life in order to detect potential changes.Constantinos ZamboglouSimon K. B. SpohnSonja AdebahrMaria HuberSimon KirsteTanja SpraveChristian GratzkeRonald C. ChenErnst Günther CarlWolfgang A. WeberMichael MixMatthias BenndorfThomas WiegelDimos BaltasCarolin JenknerAnca L. GrosuMDPI AGarticleprostate cancerstereotactic body radiotherapySBRTultra-hypofractionationmoderate hypofractionationfocal dose escalationNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENCancers, Vol 13, Iss 5795, p 5795 (2021) |
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prostate cancer stereotactic body radiotherapy SBRT ultra-hypofractionation moderate hypofractionation focal dose escalation Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 |
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prostate cancer stereotactic body radiotherapy SBRT ultra-hypofractionation moderate hypofractionation focal dose escalation Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Constantinos Zamboglou Simon K. B. Spohn Sonja Adebahr Maria Huber Simon Kirste Tanja Sprave Christian Gratzke Ronald C. Chen Ernst Günther Carl Wolfgang A. Weber Michael Mix Matthias Benndorf Thomas Wiegel Dimos Baltas Carolin Jenkner Anca L. Grosu PSMA-PET/MRI-Based Focal Dose Escalation in Patients with Primary Prostate Cancer Treated with Stereotactic Body Radiation Therapy (HypoFocal-SBRT): Study Protocol of a Randomized, Multicentric Phase III Trial |
description |
Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time, and by (ii) enabling safe delivery of high RT doses. Several studies proposed a dose–response relationship for patients with primary PCa and especially in patients with high-risk features, as dose escalation leads to improved tumor control. In parallel to the improvements in RT techniques, diagnostic imaging techniques like multiparametric magnetic resonance imaging (mpMRI) and positron-emission tomography targeting prostate-specific-membrane antigen (PSMA-PET) evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time. The HypoFocal-SBRT study combines ultra-hypofractionated RT/stereotactic body RT, with focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. This novel strategy will be compared with moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. We suspect an increase in relapse-free survival (RFS), and we will assess quality of life in order to detect potential changes. |
format |
article |
author |
Constantinos Zamboglou Simon K. B. Spohn Sonja Adebahr Maria Huber Simon Kirste Tanja Sprave Christian Gratzke Ronald C. Chen Ernst Günther Carl Wolfgang A. Weber Michael Mix Matthias Benndorf Thomas Wiegel Dimos Baltas Carolin Jenkner Anca L. Grosu |
author_facet |
Constantinos Zamboglou Simon K. B. Spohn Sonja Adebahr Maria Huber Simon Kirste Tanja Sprave Christian Gratzke Ronald C. Chen Ernst Günther Carl Wolfgang A. Weber Michael Mix Matthias Benndorf Thomas Wiegel Dimos Baltas Carolin Jenkner Anca L. Grosu |
author_sort |
Constantinos Zamboglou |
title |
PSMA-PET/MRI-Based Focal Dose Escalation in Patients with Primary Prostate Cancer Treated with Stereotactic Body Radiation Therapy (HypoFocal-SBRT): Study Protocol of a Randomized, Multicentric Phase III Trial |
title_short |
PSMA-PET/MRI-Based Focal Dose Escalation in Patients with Primary Prostate Cancer Treated with Stereotactic Body Radiation Therapy (HypoFocal-SBRT): Study Protocol of a Randomized, Multicentric Phase III Trial |
title_full |
PSMA-PET/MRI-Based Focal Dose Escalation in Patients with Primary Prostate Cancer Treated with Stereotactic Body Radiation Therapy (HypoFocal-SBRT): Study Protocol of a Randomized, Multicentric Phase III Trial |
title_fullStr |
PSMA-PET/MRI-Based Focal Dose Escalation in Patients with Primary Prostate Cancer Treated with Stereotactic Body Radiation Therapy (HypoFocal-SBRT): Study Protocol of a Randomized, Multicentric Phase III Trial |
title_full_unstemmed |
PSMA-PET/MRI-Based Focal Dose Escalation in Patients with Primary Prostate Cancer Treated with Stereotactic Body Radiation Therapy (HypoFocal-SBRT): Study Protocol of a Randomized, Multicentric Phase III Trial |
title_sort |
psma-pet/mri-based focal dose escalation in patients with primary prostate cancer treated with stereotactic body radiation therapy (hypofocal-sbrt): study protocol of a randomized, multicentric phase iii trial |
publisher |
MDPI AG |
publishDate |
2021 |
url |
https://doaj.org/article/61b329409a6840e38e51365c8dece786 |
work_keys_str_mv |
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