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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Stereotactic body radition (SBRT)
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Stereotactic body radiation therapy, Calypso® beacon system

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of GenevaRecruiting

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Full Information

First Posted
September 22, 2017
Last Updated
May 13, 2020
Sponsor
University Hospital, Geneva
Collaborators
Humanitas Hospital, Italy, University of Zurich, Kantonsspital Graubünden
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1. Study Identification

Unique Protocol Identification Number
NCT03294889
Brief Title
ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer
Official Title
ONE-SHOT - Single Shot Radiotherapy for Localized Prostate Cancer. A Multicenter, Single Arm, Phase I/II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
Humanitas Hospital, Italy, University of Zurich, Kantonsspital Graubünden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Stereotactic body radiation therapy, Calypso® beacon system

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
Stereotactic body radition (SBRT)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Clinical performance
Description
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).
Time Frame
3 months
Title
Progression free survival (PFS)
Description
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).
Time Frame
3 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Histologically confirmed adenocarcinoma of the prostate
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Zilli, MD
Phone
+41 79 55 32 563
Email
Thomas.Zilli@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence Zulianello, PhD
Phone
+ 22 372 72 05
Email
laurence.zulianello@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Zilli, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Geneva
City
Genève
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Zilli, MD
Phone
+41 79 55 32 563
Email
thomas.zilli@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Laurence Zulianello, PhD
Phone
+ 41 22 372 7205
Email
laurence.zulianello@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Giorgio Lamana, MD
First Name & Middle Initial & Last Name & Degree
Yves Chalandon, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30180867
Citation
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.
Results Reference
derived

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

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