CyberKnife for Prostate Cancer Patients Aged 70 y or More

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT03235557
• Lead Sponsor: Centre Francois Baclesse, Luxembourg

Brief Summary

Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.

Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA (Prostate Specific Antigen) \<30ng/ml.

Dose : 36.25 Gy in 5 fractions, in 10 days, considering CAPRA Scores≤5 AND 37.5 Gy in 5 fractions, in 10 days, considering CAPRA Scores\>5.

Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response.

Detailed Description

Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.

Rationale : Half of the prostatic adenocarcinoma are diagnosed in the elderly but until now curative treatments were not proven to increase overall survival rates. Therefore, very short, comfortable and safe treatments have to be designed to increase the pelvic control of the disease. Moreover, the alpha/beta ratio of the disease ≤3Gray is in favour of using hypofractionation schemes.

Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response and quality of life evaluation.

Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA\<30ng/ml.

Dose : 36.25 Gray in 5 fractions, in 10 days, considering CAPRA Score≤5 AND 37.5 Gray in 5 fractions, in 10 days, considering CAPRA Scores\>5.

Doses to the Organs At Risk (OAR) : Rectum wall : V36.25\<2%, V27\<20%, V23\<30%, V20\<35%. Bladder wall : V36.25\<2%, V27\<20%, V20\<35%. Considering specifically the prescription of 37.5 Gray, the rectum and bladder wall: V37.5\<2%. Anytime, hot spots of 105 % of the prescription dose must avoid the urethra.

Evaluation criteria : CTCAEV4 (Common Toxicity Criteria for Adverse Events, version4), PSA, multiparametric MRI, IPSS (International Prostate Score Symptom) and IIEF5 (International Index of Erectile Function).

Methodolgy : this is a three step prospective, observational study of 20 patients each step. Before moving to the next step, the severe acute or late toxicity at a median follow-up of 1 year must remain below 5% each.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-08-01
• Primary Completion: 2018-10
• Study Completion: 2021-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-20
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

• T1-T3b,
• MRI pelvic nodes negative,
• M0,
• any Gleason Score,
• PSA<30ng/ml,
• WHO (World Health Organisation) score<2, IPSS≤15,
• maximal urinary flow rate ≥15ml/s,
• mean urinary flow rate ≥5ml/s,
• multiparametric prostatic and pelvis MRI

Exclusion Criteria

• Prostatic volume > 100cc,
• TURP (transurethral prostatectomy) <3 y,
• any recurrent prostatitis within the last 3 years,
• collagenose diseases,
• ulcero-haemorrhagic rectocolitis or
• crohn diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute and late toxicity (Using the CTCAEv4)	During 36 months after treatment	Using the CTCAEv4

Secondary Outcome Measures

Name	Time	Method
Birads score evaluation	at 36 months	Multiparametric prostatic MRI
PSA evaluation	at 4 and 6 months, than every 6 months for 3 years	PSA Dosage
Digital rectal exam	at 6, 12, 24 and 36 months	Clinical examination (digital rectal exam)
IIEF5 evaluation	at 12, 24 and 36 months	IIEF5 score
IPSS evaluation	at 12, 24 and 36 months	IPSS score

Trial Locations

Locations (1)

Centre Francois Baclesse; 🇱🇺 Esch Sur Alzette, Luxembourg