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

NCT ID: NCT03294889

Last Updated: 2020-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2030-10-01

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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)

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Humanitas Hospital, Italy

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: collaborator

Kantonsspital Graubünden

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Thomas Zilli

Médecin Adjoint Agrégé

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Zilli, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

University Hospital of Geneva

Geneva, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Thomas Zilli, MD

Role: CONTACT

Thomas.Zilli@hcuge.ch

+41 79 55 32 563

Laurence Zulianello, PhD

Role: CONTACT

laurence.zulianello@hcuge.ch

+ 22 372 72 05

Facility Contacts

Thomas Zilli, MD

Role: primary

thomas.zilli@hcuge.ch

+41 79 55 32 563

Laurence Zulianello, PhD

Role: backup

laurence.zulianello@hcuge.ch

+ 41 22 372 7205

References

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.

Reference Type: DERIVED

PMID: 30180867 (View on PubMed)

Other Identifiers

2017-01236

Identifier Type: -

Identifier Source: org_study_id