Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma

• Conditions: Prostate Cancer

• Registration Number: NCT03284151
• Lead Sponsor: Centre Francois Baclesse, Luxembourg

Brief Summary

Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

Detailed Description

Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

Second objectives : objectives: prostate-specific antigen (PSA) response, MRI response, toxicity (CTCAEv4), quality of life (International Prostate Symptom Score (IPSS) and The International Index of Erectile Function (IIEF5) scores).

Method At first: Multiparametric Magnetic resonance imaging (MRI) - 12 biopsies within the whole gland.

Placement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced.

Treatment : CyberKnife radiation treatment delivering 36.25 Gy in 5 fractions, in 10 days. Tracking using the 4 fiducials. Critical organs: Rectal and bladder wall: V35\<2cc. Bladder neck and urethra: V35\<1cc.

Salvage treatments: in such a context, salvage surgery or salvage intensity modulation radiation therapy (IMRT) treatments can in theory remain valid and safe options.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-15
• Primary Completion: 2020-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-20
• Last Update Posted: 2022-06-22
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

• Prostatic adenocarcinoma of Capra score≤2 invading no more than two adjacent of the 12 prostatic zones. Lesions>3mm. Maximal urinary flow rate ≥ 10ml/s, mean flow rate ≥ 5ml/s, post micturation volume ≤80ml, IPSS score ≤15.

Exclusion Criteria

• systemic disease, ulcerative hemorrhagic ulcer or Crohn diseases, bladder neck stenosis, urethral implants, transurethral prostatectomy (TURP), any recurrent prostatitis within the last 3 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delay between the initial diagnosis and date of salvage treatment	through study completion, up to 36 months	Delay between the initial diagnosis and date of salvage treatment

Secondary Outcome Measures

Name	Time	Method
Acute and late toxicity	3, 6, 12, 18, 24, 30, 36 months	Acute and late toxicity using the CTCAEv4
IIEF5 evaluation	12, 24, 36 months	IIEF5 score
Birads score evaluation	12, 24, 36 months	Multiparametric prostatic MRI
IPSS evaluation	12, 24, 36 months	IPSS score
PSA evaluation	3, 6, 12, 18, 24, 30, 36 months	PSA dosage

Trial Locations

Locations (1)

Centre Francois Baclesse; 🇱🇺 Esch Sur Alzette, Luxembourg