Prostate Cancer
Conditions
Brief summary
The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology using electromagnetic transponders implanted within the prostate. It is a real-time target tracking system that takes into account both inter- and intrafractional target motion. So the exact position and movement of the prostate can be determined during radiation therapy treatment. The aim of this study is to assess pelvic late toxicity rate after intensity-modulated radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In this randomized study, patients will receive IGRT treatment using the Calypso system or a conventional IGRT treatment.
Detailed description
Prostate cancer is the most frequent cancer in men. Radiotherapy is one of the reference treatments for localized prostate cancer. Prostate was initially thought to be a non-moving target, but the newest reports have raised the contrary as evidence. Image-guided radiotherapy (IGRT) is a current standard treatment for localized prostate cancer which enables to take into account interfractional prostate motion before treatment. The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology using electromagnetic transponders implanted within the prostate. It is a real-time target tracking system that takes into account both inter- and intrafractional target motion. So the exact position and movement of the prostate can be determined during radiation therapy treatment. As Planned Target Volume (PTV) margins integrate set-up margins and the management of organ motion, margin reduction can reasonably be considered in case of target motion management improvement. To date, no prospective randomized clinical data is available using this technique for the treatment of low- or intermediate-risk prostate cancer patients with modern standard fractionation radiotherapy and image guidance. The aim of this study is to assess pelvic late toxicity rate after intensity-modulated radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In this randomized study, patients will receive IGRT treatment using the Calypso system or a conventional IGRT treatment.
Interventions
DEVICECalypso beacon implant
Calypso beacon implant before radiotherapy
RADIATIONmoderate hypofractionation Radiotherapy
moderate hypofractionation Radiotherapy
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Localized prostate cancer, histologically proven. * No evidence of metastases (M0). No evidence of lymph nodes involvement (N0) (bilateral lymph node dissection is not mandatory if lymph node involvement risk is low according to the Partin tables). * Low-risk or intermediate clinical stage according to the D'Amico classification (T1-T2 and Gleason \< 8 and PSA \< 20 ng/ml) (appendix 3). * No grade \> 2 urinary or rectal clinical sign or symptom according to the CTCAE V4.03 scale. * Performance status ECOG ≤ 1. * No hip prosthesis or metallic vascular graft near the prostate. * No endopenian stent. * No pace maker, implanted defibrillator or neurostimulator. * No allergy to local anesthetics. * No irreversible anticoagulation or antiplatelet treatment for the implantation period. * Pelvic and abdominal anatomy compatible with the use of the Calypso® system (predictive detector to fiducials distance less than 19 cm, evaluated on planning CT-scan) (distance from skin surface to prostate center less than 17 cm). * Patient aged ≥ 18 and less than 80 years old. * Dated and signed written informed consent available. * Patients must be affiliated to a French Social Security System.
Exclusion criteria
* Indication of pelvic nodes irradiation. * Prior pelvic irradiation. * Biopsy-proven seminal vesicle invasion. * Prior bilateral orchiectomy. * Prior radical prostatectomy. * Other malignancy except adequately-treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease-free for at least 5 years. * Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. * Other uncontrolled systemic disease (cardiovascular, renal, liver, pulmonary embolism, etc.). * Known VIH positive patients (no specific test needed). * Known homozygote ATM Mutation (Ataxia telengiectasia).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Grade > 2 Late Pelvic Toxicities | between 3 months and 2 years after radiation period | assessment of grade \> 2 late pelvic toxicities between 3 months and 2 years after radiation period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biological Relapse-free Survival | at 5 years after the radiotherapy | evaluate at 5 years with PSA dosage |
| Uncomplicated Survival (Local Recurrence or Metastatic Recurrence) | at 5 years after the radiotherapy | evaluate et 5 years after the treatment with radiological exam |
| Overall Survival | from the baseline to 5 years after the radiotherapy | number of death from baseline to 5 years after the treatment |
Countries
France
Contacts
STUDY_CHAIRRiou Olivier
Institut régional du Cancer de Montpellier
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Image-guided Radiation Therapy (IGRT) With Standard Margins moderate hypofractionation during 4 weeks
moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy | 29 |
| Calypso Tracking System With Margin Reduction moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before
Calypso beacon implant: Calypso beacon implant before radiotherapy
moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy | 45 |
| Total | 74 |
Baseline characteristics
| Characteristic | Image-guided Radiation Therapy (IGRT) With Standard Margins | Calypso Tracking System With Margin Reduction | Total |
|---|---|---|---|
| Age, Continuous | 68 years | 70 years | 69.5 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 29 Participants | 45 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 2 / 44 |
| other Total, other adverse events | 26 / 26 | 44 / 44 |
| serious Total, serious adverse events | 2 / 26 | 9 / 44 |
Outcome results
Primary
Assessment of Grade > 2 Late Pelvic Toxicities
assessment of grade \> 2 late pelvic toxicities between 3 months and 2 years after radiation period
Time frame: between 3 months and 2 years after radiation period
Population: failure : presence of grade \> 2 late pelvic toxicities between 3 months and 2 years after radiation period success : absence of grade \> 2 late pelvic toxicities between 3 months and 2 years after radiation period
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Image-guided Radiation Therapy (IGRT) With Standard Margins | Assessment of Grade > 2 Late Pelvic Toxicities | failure | 5 Participants |
| Image-guided Radiation Therapy (IGRT) With Standard Margins | Assessment of Grade > 2 Late Pelvic Toxicities | success | 21 Participants |
| Calypso Tracking System With Margin Reduction | Assessment of Grade > 2 Late Pelvic Toxicities | failure | 5 Participants |
| Calypso Tracking System With Margin Reduction | Assessment of Grade > 2 Late Pelvic Toxicities | success | 39 Participants |
Secondary
Biological Relapse-free Survival
evaluate at 5 years with PSA dosage
Time frame: at 5 years after the radiotherapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Image-guided Radiation Therapy (IGRT) With Standard Margins | Biological Relapse-free Survival | 26 participants |
| Calypso Tracking System With Margin Reduction | Biological Relapse-free Survival | 37 participants |
Secondary
Overall Survival
number of death from baseline to 5 years after the treatment
Time frame: from the baseline to 5 years after the radiotherapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Image-guided Radiation Therapy (IGRT) With Standard Margins | Overall Survival | 0 participants |
| Calypso Tracking System With Margin Reduction | Overall Survival | 2 participants |
Secondary
Uncomplicated Survival (Local Recurrence or Metastatic Recurrence)
evaluate et 5 years after the treatment with radiological exam
Time frame: at 5 years after the radiotherapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Image-guided Radiation Therapy (IGRT) With Standard Margins | Uncomplicated Survival (Local Recurrence or Metastatic Recurrence) | 26 participants |
| Calypso Tracking System With Margin Reduction | Uncomplicated Survival (Local Recurrence or Metastatic Recurrence) | 41 participants |