Single Fraction Early Prostate Irradiation (SiFEPI)

Prostate Cancer Clinical Trial

— SiFEPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104362
• Other study ID #: 2013-A01514-41
• Secondary ID: 2013/16
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: June 14, 2021

Study information

• Verified date: October 2021
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 14, 2021
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• exclusive single-fraction irradiation

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Local recurrence-free survival at 5 years		up to 5 years
Primary	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	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

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