JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03294889

Studienbeginn:
September 2017

Letztes Update:
14.05.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Geneva

Collaborator:
Humanitas Hospital, Italy, University of Zurich, Kantonsspital Graubünden,

Studienleiter

Thomas Zilli, MD
Principal Investigator
University Hospital, Geneva

Kontakt

Thomas Zilli, MD
Kontakt:
Phone: +41 79 55 32 563
E-Mail: Thomas.Zilli@hcuge.ch» Kontaktdaten anzeigen

Laurence Zulianello, PhD
Kontakt:
Phone: + 22 372 72 05
E-Mail: laurence.zulianello@hcuge.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital of Geneva
1205 Genève
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Thomas Zilli, MD
Phone: +41 79 55 32 563
E-Mail: thomas.zilli@hcuge.ch

Laurence Zulianello, PhD
Phone: + 41 22 372 7205
E-Mail: laurence.zulianello@hcuge.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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).

2. 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).

Geprüfte Regime

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)

Quelle: ClinicalTrials.gov

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