CyberKnife for Prostate Cancer Patients Aged 70 y or More (ProRobot)

June 20, 2022 updated by: Centre Francois Baclesse, Luxembourg

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Luxembourg
      • Esch Sur Alzette, Luxembourg, 4005
        • Centre François Baclesse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Elderly patients suffering prostatic adenocarcinoma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute and late toxicity (Using the CTCAEv4)
Time Frame: During 36 months after treatment
Using the CTCAEv4
During 36 months after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse, Luxembourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

December 1, 2021

Study Registration Dates

First Submitted

January 15, 2015

First Submitted That Met QC Criteria

July 27, 2017

First Posted (ACTUAL)

August 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYM Prostate CFB 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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