Clinical trial NCT03254420: Evaluation of Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins.
Official title: Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 74
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Assessment of Grade > 2 Late Pelvic Toxicities
timeFrame: between 3 months and 2 years after radiation period
Secondary outcomes:
measure: Biological Relapse-free Survival
timeFrame: at 5 years after the radiotherapy
measure: Uncomplicated Survival (Local Recurrence or Metastatic Recurrence)
timeFrame: at 5 years after the radiotherapy
measure: Overall Survival
timeFrame: from the baseline to 5 years after the radiotherapy
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut regional du Cancer - Val d Aurelle
Study officials:
affiliation: Institut régional du Cancer de Montpellier
name: Riou Olivier
role: STUDY_CHAIR
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