Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer
Overview
- Phase
- Phase 3
- Intervention
- treatment with focal HIFU
- Conditions
- Prostate Cancer
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 108
- Locations
- 14
- Primary Endpoint
- patient proportion who needed to seek radical treatment
- Status
- Active, Not Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
The percentage of malignant prostate tumors detected very early is constantly increasing and the number of well differentiated tumors, with small volume and low risk of progression increases. When a tumor of this type is identified, radical prostatectomy remains the reference treatment, but this treatment is not without side effects. Active surveillance is a strategy which aims at detecting an early development of the cancerous disease in order to propose curative treatment in a timely manner and thus improve specific survival. Patients are therefore re-evaluated each year by rectal examination, PSA (Prostate-Specific Antigen) assay. Active surveillance remains difficult to manage psychologically for both the patient and the practitioner, because of the lack of treatment on the one hand and a rate of non-curable cancers close to 50% when signs of progression trigger a radical treatment.
The aim of the focal treatment HIFU (High Intensity Focused Ultrasound) is to destroy the cancer without causing side effects in contrast to radical treatments. It is in this sense that it is positioned both as an alternative to radical surgery and as an alternative to active surveillance.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
- •Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have G8 score \>
- •Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:
- •Only one Target tumor on MRI on a maximum of 2 contigous sextants. Case allowed:
- •If more than one target tumor on MRI, only one of them must be confirmed by targeted prostate biopsies.
- •If no target tumor on MRI, only 2 contigous sextants must be positive on prostate biopsies
- •A maximum tumor length\> 3 mm or at least 3 positive biopsies on all biopsies performed (randomized biopsies and/or MRI/Ultrasound Fusion-Guided Prostate Biopsy).
- •Gleason 6 score (risk group 1 of the D'Amico classification).
- •Tumor positioned so that a safety distance of at least 9 mm from external sphincter can be defined during HIFU-FOCAL treatment in prostate tissue around the target.
- •PSA ≤ 15ng / ml.
Exclusion Criteria
- •Contraindications to treatment with HIFU-F:
- •Tumor not accessible.
- •Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment.
- •History of pelvic irradiation
- •Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
- •Fistula of the urinary tract or rectum.
- •Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe.
- •Anatomical abnormality of the rectum or rectal mucosa.
- •Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent.
- •History of intestinal inflammatory pathology.
Arms & Interventions
HIFU treatment
65 patients will receive the immediate treatment with focal HIFU in order to destroy the cancer without causing side effects. HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients randomized in this arm will also have PSA dosage, MRI exam, questionnaires and prostatic biopsies during their follow up.
Intervention: treatment with focal HIFU
HIFU treatment
65 patients will receive the immediate treatment with focal HIFU in order to destroy the cancer without causing side effects. HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients randomized in this arm will also have PSA dosage, MRI exam, questionnaires and prostatic biopsies during their follow up.
Intervention: PSA dosage
HIFU treatment
65 patients will receive the immediate treatment with focal HIFU in order to destroy the cancer without causing side effects. HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients randomized in this arm will also have PSA dosage, MRI exam, questionnaires and prostatic biopsies during their follow up.
Intervention: MRI
HIFU treatment
65 patients will receive the immediate treatment with focal HIFU in order to destroy the cancer without causing side effects. HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients randomized in this arm will also have PSA dosage, MRI exam, questionnaires and prostatic biopsies during their follow up.
Intervention: Questionnaires
HIFU treatment
65 patients will receive the immediate treatment with focal HIFU in order to destroy the cancer without causing side effects. HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients randomized in this arm will also have PSA dosage, MRI exam, questionnaires and prostatic biopsies during their follow up.
Intervention: Prostatic biopsies
Active surveillance
65 patients will be randomized to active surveillance and will have exactly the same follow-up as treated patients excepting the HIFU treatment. Active surveillance is a therapeutic option that shifts the eventual moment of curative treatment while remaining within a window of curability of the disease. Patients randomized in this arm will also have PSA dosage, MRI exam, questionnaires and prostatic biopsies during their follow up.
Intervention: PSA dosage
Active surveillance
65 patients will be randomized to active surveillance and will have exactly the same follow-up as treated patients excepting the HIFU treatment. Active surveillance is a therapeutic option that shifts the eventual moment of curative treatment while remaining within a window of curability of the disease. Patients randomized in this arm will also have PSA dosage, MRI exam, questionnaires and prostatic biopsies during their follow up.
Intervention: MRI
Active surveillance
65 patients will be randomized to active surveillance and will have exactly the same follow-up as treated patients excepting the HIFU treatment. Active surveillance is a therapeutic option that shifts the eventual moment of curative treatment while remaining within a window of curability of the disease. Patients randomized in this arm will also have PSA dosage, MRI exam, questionnaires and prostatic biopsies during their follow up.
Intervention: Questionnaires
Active surveillance
65 patients will be randomized to active surveillance and will have exactly the same follow-up as treated patients excepting the HIFU treatment. Active surveillance is a therapeutic option that shifts the eventual moment of curative treatment while remaining within a window of curability of the disease. Patients randomized in this arm will also have PSA dosage, MRI exam, questionnaires and prostatic biopsies during their follow up.
Intervention: Prostatic biopsies
Outcomes
Primary Outcomes
patient proportion who needed to seek radical treatment
Time Frame: 48 month
The primary endpoint is the comparison between the 2 groups of the proportion of patient converting to a radical treatment at 48 months of follow-up. Conversion to a radical treatment is define as a medical decision based on the following criteria: * An increase in Gleason score to a score 7 (3 + 4) with bilateral involvement (Gleason 6 or 7). * An increase in the Gleason score to a score 7 (3 + 4) with tumor whose location is not compatible with a focal treatment (impossibility to apply safety margins of 9mm). * An increase in Gleason score to a score of 7 (4 + 3) or higher. * Risk of lymph node invasion\> 5% (calculated with the MSKCC nomogram) * An extension of the tumor beyond the prostatic capsule (MRI and / or biopsies). * Appearance of pelvic ganglion metastases.
Secondary Outcomes
- Appearance of another cancerous focus in the other half of the prostate(48 months)
- Proportion of serious adverse effect(48 months)
- STAi-YB score(Over the 48 months)
- proportion of patients needing additional treatment(48 months)
- Overall survival(48 months)
- Prostate cancer specific survival(48 months)
- Recurrence free survival(48 months)
- EPIC-26 score(over the 48 months)
- Gleason score(48 months)
- IIEF-5 score(over the 48 months)
- clinically significant cancer rate(48 months)
- rate of positive biopsies(48 months)
- IPSS score(over the 48 months)
- Quality of life score(over the 48 months)
- Appearance of metastases(48 months)
- Appearance of an extra capsular extension(48 months)