Single Fraction Early Prostate Irradiation (SiFEPI)
Study Details
Study Description
Brief Summary
Recently, HDR brachytherapy delivering only a 19 Gy fraction was proposed as exclusive treatment for low and intermediate risk prostate cancers. With a median 3-year follow-up, the Spanish team reported a biochemical control rate of 100% and 87%, respectively, for low risk and intermediate risk tumors. In parallel with these encouraging results regarding biochemical control, the authors described excellent urinary and digestive tolerance, notably the absence of grade > 2 complications. However, it should be noted, in this study, that special protection was provided to the anterior aspect of the rectum by means of a 10 ml transperineal injection of hyaluronic acid into the prostate-rectal interspace.
The idea of using a single high dose (in one fraction) was proposed at the MSKCC by the team of Fucks et al. which, in 2008, following a median 18-month follow-up, published a a 90% local control rate for spinal metastases after a single dose at 18 to 24 Gy.
The aim of the present study is to analyze acute urinary and digestive toxicity (< 180 days) observed following interstitial high dose rate prostate brachytherapy delivering a total dose of 20 Gy in one fraction.
Condition or Disease | Intervention/Treatment | Phase |
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|
N/A |
Detailed Description
Expected benefit(s) of the trial
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Improved quality of life during brachytherapy on account of the absence of radioactive seeds in the prostate:
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Fewer early urinary complications,
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No urine filtration,
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No post-operative use of condoms,
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No 2-year ban on cremation following treatment,
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Health cost savings,
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Acquisition of dosimetric data for inverse optimization.
Predictable risk(s) for patients Predictable risks in the context of this trial involve the frequency of essentially urinary disorders.
Methodology Open, monocentric, phase I-II study.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: exclusive single-fraction irradiation
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Radiation: exclusive single-fraction irradiation
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Outcome Measures
Primary Outcome Measures
- acute urinary toxicity occurring within 6 months after irradiation. [up to 5 years]
to assess the acute urinary toxicity occurring within 6 months after irradiation.
Secondary Outcome Measures
- acute digestive toxicity occurring during the 6 months following irradiation [up to 5 years]
Assessment of acute digestive toxicity occurring during the 6 months following irradiation,
Other Outcome Measures
- Local recurrence-free survival at 5 years [up to 5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients suffering from histologically-proven adenocarcinoma-type prostate cancer:
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with low risk of biochemical recurrence
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with a low intermediate risk of biochemical recurrence (maximum of 1 intermediate risk factor)*
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stage T1c, T2a, T2b
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Gleason score 6 (3+3) or 7 (3+4) with at most 3 positive biopsies
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PSA < 15 ng/ml
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Age ≥ 18 years
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Karnofsky index ≥ 70%
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Life expectancy ≥ 10 years
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No contraindication to injection of hyaluronic acid in the prostate-rectal interspace
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Patient aware of the information leaflet and having signed the informed consent form
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Patient covered by medical insurance
Exclusion Criteria:
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Stage ≥ T2c
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Gleason score 7 (4+3) or ≥ 8
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PSA > 15 ng/ml
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Presence of the following anatomico-pathological criteria:
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Involvement of the nerve fibers
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Peri-tumoral vascular embolisms
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Capsule involvement
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Number of positive biopsies ≥ 50%
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100% positive biopsies in a lobe
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Involvement of the seminal vesicle
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Prostate volume ≥60 cc
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Large prostatic transurethral resection and/or dating from less than 6 months
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Poor urinary function in the absence of alpha-blockers
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IPSS score > 15
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Post-mictional residue > 50 cc
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Flow rate with Qmax < 12 ml/s
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Remote metastasis
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Neoadjuvant anti-androgenic treatment
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Prior treatment with pelvic irradiation and/or chemotherapy
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Active infection or other underlying severe pathology likely to prevent the patient from receiving treatment
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History of cancer other than basocellular cutaneous cancer or other form of cancer in complete remission for more than 5 years
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Evolving psychiatric disorder
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Vulnerable persons as defined by article L1121-5 to -8
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Centre Antoine Lacassagne | Nice | France | 06000 |
Sponsors and Collaborators
- Centre Antoine Lacassagne
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2013-A01514-41
- 2013/16