Single Fraction Early Prostate Irradiation (SiFEPI)

Study Overview
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Brief Summary
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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.

Detailed Description
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Expected benefit(s) of the trial Improved quality of life during brachytherapy on account of the absence of radioactive seeds in the prostate: Fewer early urinary complications, No urine filtration, No post-operative use of condoms, No 2-year ban on cremation following treatment, Health cost savings, 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.

Official Title
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A Phase I-II Study to Evaluate Exclusive Single-fraction Irradiation by Interstitial High Dose Rate Brachytherapy in Patients With Prostate Cancer at Low Risk or at Low Intermediate Risk of Local Recurrence

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: exclusive single-fraction irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from histologically-proven adenocarcinoma-type prostate cancer: with low risk of biochemical recurrence with a low intermediate risk of biochemical recurrence (maximum of 1 intermediate risk factor)* stage T1c, T2a, T2b Gleason score 6 (3+3) or 7 (3+4) with at most 3 positive biopsies PSA < 15 ng/ml Age ≥ 18 years Karnofsky index ≥ 70% Life expectancy ≥ 10 years No contraindication to injection of hyaluronic acid in the prostate-rectal interspace Patient aware of the information leaflet and having signed the informed consent form Patient covered by medical insurance Exclusion Criteria: Stage ≥ T2c Gleason score 7 (4+3) or ≥ 8 PSA > 15 ng/ml Presence of the following anatomico-pathological criteria: Involvement of the nerve fibers Peri-tumoral vascular embolisms Capsule involvement Number of positive biopsies ≥ 50% 100% positive biopsies in a lobe Involvement of the seminal vesicle Prostate volume ≥60 cc Large prostatic transurethral resection and/or dating from less than 6 months Poor urinary function in the absence of alpha-blockers IPSS score > 15 Post-mictional residue > 50 cc Flow rate with Qmax < 12 ml/s Remote metastasis Neoadjuvant anti-androgenic treatment Prior treatment with pelvic irradiation and/or chemotherapy Active infection or other underlying severe pathology likely to prevent the patient from receiving treatment History of cancer other than basocellular cutaneous cancer or other form of cancer in complete remission for more than 5 years Evolving psychiatric disorder Vulnerable persons as defined by article L1121-5 to -8

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: exclusive single-fraction irradiation<br> | Radiation: exclusive single-fraction irradiation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute urinary toxicity occurring within 6 months after irradiation. | to assess the acute urinary toxicity occurring within 6 months after irradiation. | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute digestive toxicity occurring during the 6 months following irradiation | Assessment of acute digestive toxicity occurring during the 6 months following irradiation, | up to 5 years |