CyberKnife for Prostate Cancer Patients Aged 70 y or More

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03235557
Study type	Observational [Patient Registry]
Source	Centre Francois Baclesse, Luxembourg
Contact
Status	Completed
Phase
Start date	October 2014
Completion date	December 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

CyberKnife for Prostate Cancer Patients Aged 70 y or More — ProRobot

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms