CyberKnife for Prostate Cancer Patients Aged 70 y or More

Prostate Cancer Clinical Trial

— ProRobot  

Official title:

Robotic Radiation Treatment of Prostate Cancer Patients Aged 70 y or More

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235557
• Other study ID #: CYM Prostate CFB 1
• Status: Completed
• Start date: October 2014
• Est. completion date: December 2021

Study information

• Verified date: June 2022
• Source: Centre Francois Baclesse, Luxembourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2021
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Luxembourg	Centre Francois Baclesse	Esch Sur Alzette

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse, Luxembourg

Country where clinical trial is conducted

Luxembourg, 

References & Publications (3)

Boike TP, Lotan Y, Cho LC, Brindle J, DeRose P, Xie XJ, Yan J, Foster R, Pistenmaa D, Perkins A, Cooley S, Timmerman R. Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer. J Clin Oncol. 2011 — View Citation

King CR, Brooks JD, Gill H, Presti JC Jr. Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):877-82. doi: 10.1016/j.ijrobp.2010.11.054. Epub 2011 Feb 6 — View Citation

Nickers P, Hermesse J, Deneufbourg JM, Vanbelle S, Lartigau E. Which a/ß ratio and half-time of repair are useful for predicting outcomes in prostate cancer? Radiother Oncol. 2010 Dec;97(3):462-6. doi: 10.1016/j.radonc.2010.06.006. Epub 2010 Aug 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute and late toxicity (Using the CTCAEv4)	Using the CTCAEv4	During 36 months after treatment
Secondary	PSA evaluation	PSA Dosage	at 4 and 6 months, than every 6 months for 3 years
Secondary	Digital rectal exam	Clinical examination (digital rectal exam)	at 6, 12, 24 and 36 months
Secondary	Birads score evaluation	Multiparametric prostatic MRI	at 36 months
Secondary	IPSS evaluation	IPSS score	at 12, 24 and 36 months
Secondary	IIEF5 evaluation	IIEF5 score	at 12, 24 and 36 months