Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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)

Stereotactic body radition (SBRT)

Thomas Zilli, MD

Laurence Zulianello, PhD

Giorgio Lamana, MD

Yves Chalandon, MD

The main objective of the phase I/II trial is to determine the safety and efficacy of a single fraction SBRT at a dose of 19 Gy in patients with localized prostate cancer.

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.

Histologically confirmed adenocarcinoma of the prostate

ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer

ONE-SHOT - Single Shot Radiotherapy for Localized Prostate Cancer. A Multicenter, Single Arm, Phase I/II Trial

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).

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer	NCT03294889	Prostate Cancer	Stereotactic bo...	18 Years - 85 Years	University Hospital, Geneva
ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer	NCT03294889	Prostate Cancer	Stereotactic bo...	18 Years - 85 Years	University Hospital, Geneva

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