Clinical Trials Logo
NCT number NCT03294889
Study type Interventional
Source University Hospital, Geneva
Contact Thomas Zilli, MD
Phone +41 79 55 32 563
Email Thomas.Zilli@hcuge.ch
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date October 1, 2017
Completion date October 1, 2020

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT03177759 - Living With Prostate Cancer (LPC) N/A
Recruiting NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data N/A
Recruiting NCT02945813 - SAKK 08/15 - PROMET - Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy Phase 2
Recruiting NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A
Completed NCT02124668 - A Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy Phase 2
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Active, not recruiting NCT00779168 - White Button Mushroom Extract in Treating Patients With Recurrent Prostate Cancer After Local Therapy Phase 1
Recruiting NCT02799706 - Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer Phase 3
Recruiting NCT01990196 - Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer Phase 2
Recruiting NCT02766543 - Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer Phase 2
Recruiting NCT03134027 - Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers N/A
Not yet recruiting NCT03263780 - High Resolution PET-MRI Before Prostate Cancer HIFU Early Phase 1
Not yet recruiting NCT03264456 - Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI Phase 2
Not yet recruiting NCT03284684 - Kinetics of Perioperative Circulating DNA in Cancer Surgery N/A
Not yet recruiting NCT03276572 - Phase I Trial of 225Ac−J591 in Patients With mCRPC Phase 1
Not yet recruiting NCT03256630 - Evaluation of Urine and Blood Biomarkers to Try and Distinguish Between the Presence or Absence of Aggressive Prostate Cancer N/A
Recruiting NCT02916537 - A Phase 1 Trial for Safety and Imaging Evaluation of CTT1057, a Small Molecule Inhibitor of Prostate Specific Membrane Antigen (PSMA) Phase 1
Recruiting NCT02906241 - PACCT: Partnering Around Cancer Clinical Trials N/A