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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Stereotactic body radition (SBRT)

Detailed Description

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
• Enrollment (Anticipated): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Laurence Zulianello, PhD; Phone Number: + 22 372 72 05; Email: laurence.zulianello@hcuge.ch

Study Locations

• Switzerland
  • Genève, Switzerland, 1205
    • Recruiting
    • University Hospital of Geneva
    • Contact: Laurence Zulianello, PhD; Phone Number: + 41 22 372 7205; Email: laurence.zulianello@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
• Histologically confirmed adenocarcinoma of the prostate without small cell features
• Tumor clinical stage cT1c-2c, pN0 or cN0, M0, according to UICC TNM 2009
• MRI staging must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c
• Gleason score at biopsy 3+3 or 3+4 (WHO 2016 Grade Groups 1, 2)
• PSA ≤15 ng/ml
• WHO performance status 0-1
• International Prostate Symptom Score ≤ 10 (alpha blockers allowed)
• MRI-based volume estimation of prostate gland ≤ 70 cc
• Patient agrees not to father a child during trial treatment and during 6 months thereafter

Exclusion Criteria:

• Tumor clinical stage cT3a-3b or T4
• Evidence of T3a, T3b or T4 disease as assessed by MRI
• Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies.
• Significant tumor on the transitional zone as assessed by MRI
• Gleason at biopsy ≥ 4+3
• Androgen deprivation therapy or products known to affect PSA levels
• Impossibility to implant Calypso beacons
• History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration with the exception of curatively treated localized non-melanoma skin cancer
• Prior pelvic radiotherapy
• Previous surgery for prostate cancer
• Previous transurethral resection of the prostate (TURP) (< 12 weeks before registration)
• Hip prosthesis
• Severe or active co-morbidity likely to impact on the advisability of SBRT
• Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance	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).	3 months
Progression free survival (PFS)	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).	3 years

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: University of Zurich; Humanitas Hospital, Italy; Kantonsspital Graubünden
• Investigators: Principal Investigator: Thomas Zilli, MD, University Hospital, Geneva

Publications and helpful links

General Publications

• Zilli T, Scorsetti M, Zwahlen D, Franzese C, Forster R, Giaj-Levra N, Koutsouvelis N, Bertaut A, Zimmermann M, D'Agostino GR, Alongi F, Guckenberger M, Miralbell R. ONE SHOT - single shot radiotherapy for localized prostate cancer: study protocol of a single arm, multicenter phase I/II trial. Radiat Oncol. 2018 Sep 4;13(1):166. doi: 10.1186/s13014-018-1112-0. Erratum In: Radiat Oncol. 2018 Sep 19;13(1):182.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): October 1, 2030

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (ACTUAL): September 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Prostate cancer; Stereotactic body radiation therapy; Calypso® beacon system
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2017-01236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No