ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03294889|
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : May 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Stereotactic body radition (SBRT)||Phase 1 Phase 2|
Total dose and dose per fraction play an important role in the curative treatment of prostate cancer with radiotherapy (RT). Modern image guided external RT allows safe dose escalation of prostate cancer. There are strong radiobiological and clinical considerations that suggest that treatment with a small number of large fractions (hypofractionation) may increase the therapeutic ratio of RT for prostate cancer by increasing the tumor cell killing effect with relatively less toxic effect on the surrounding late responding normal tissues compared to conventional fractionation.
The question of how far can the number of fractions with SBRT be reduced is an exciting research matter with an undoubtful goal, face the challenge of assessing the potential for cure of prostate cancer patients with a single and unique fraction of high dose irradiation similar to what is already undertaken with radiosurgery against brain, lung, and liver targets.
We hypothesize that an ultra-hypofractionated single-dose SBRT employing state of the art of image-guided RT techniques may be feasible, with a safe toxicity profile and an optimal long-term tumor control. Hence, a prospective phase I/II clinical trial will be initiated in prostate cancer patients with a localized disease to validate this treatment schedule as an alternative to normofractionated/moderate hypofractionated RT schedules to be tested in a second time in a phase III trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ONE-SHOT - Single Shot Radiotherapy for Localized Prostate Cancer. A Multicenter, Single Arm, Phase I/II Trial|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||October 1, 2030|
- Radiation: Stereotactic body radition (SBRT)
Ultra-hypofractionated single-fraction SBRT with urethra-sparing with image-guidance and intra-fractional control motion with the Calypso® system.
- 19 Gy in a single fraction to the whole prostate gland ± proximal seminal vesicles
- 17 Gy in a single fraction to the urethra planning-risk volume (PRV)
- Clinical performance [ Time Frame: 3 months ]Toxicity will be evaluated using Grade ≥ 3 genitourinary and/or gastrointestinal acute adverse event (AE) during the first 3 month according to CTCAE classification v.4.03 (Phase I).
- Progression free survival (PFS) [ Time Frame: 3 years ]The primary endpoint is 3-years biochemical relapse free survival (bRFS). bRFS and its 97.5% one-sided confidence interval (CI) will be determined using the Kaplan Meier method. If the expected value of 96% isn't included in this interval, the efficacy of the experimental treatment will be questioned. (Phase II).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294889
|Contact: Thomas Zilli, MD||+41 79 55 32 563||Thomas.Zilli@hcuge.ch|
|Contact: Laurence Zulianello, PhD||+ 22 372 72 firstname.lastname@example.org|
|University Hospital of Geneva||Recruiting|
|Genève, Switzerland, 1205|
|Contact: Thomas Zilli, MD +41 79 55 32 563 email@example.com|
|Contact: Laurence Zulianello, PhD + 41 22 372 7205 firstname.lastname@example.org|
|Sub-Investigator: Giorgio Lamana, MD|
|Sub-Investigator: Yves Chalandon, MD|
|Principal Investigator:||Thomas Zilli, MD||University Hospital, Geneva|