Single Fraction Early Prostate Irradiation (SiFEPI)

Centre Antoine Lacassagne

Status

Completed

Conditions

Prostate Cancer

Treatments

Radiation: exclusive single-fraction irradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT02104362

2013-A01514-41

2013/16 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

35 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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