CyberKnife for Prostate Cancer Patients Aged 70 y or More

NCT03235557 | Completed DMC

• 1 other identifier: CYM Prostate CFB 1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate; cancer; radiation; stereotactic; CyberKnife; elderly

Outcome Measures

Primary Outcomes (1)

• Acute and late toxicity (Using the CTCAEv4)

  Using the CTCAEv4

  During 36 months after treatment

Secondary Outcomes (5)

• PSA evaluation

  at 4 and 6 months, than every 6 months for 3 years

• Digital rectal exam

  at 6, 12, 24 and 36 months

• Birads score evaluation

  at 36 months

• IPSS evaluation

  at 12, 24 and 36 months

• IIEF5 evaluation

  at 12, 24 and 36 months

Eligibility Criteria

• Age: 70 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients suffering prostatic adenocarcinoma

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Francois Baclesse, Luxembourg: lead

Study Sites (1)

Centre Francois Baclesse

Esch-sur-Alzette, 4005, Luxembourg

Location

Related Publications (3)

• Nickers P, Hermesse J, Deneufbourg JM, Vanbelle S, Lartigau E. Which alpha/beta 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.

  PMID: 20724012 RESULT

• 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 May 20;29(15):2020-6. doi: 10.1200/JCO.2010.31.4377. Epub 2011 Apr 4.

  PMID: 21464418 RESULT

• 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.

  PMID: 21300474 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Philippe Nickers, MD, PhD

  Centre Francois Baclesse

  STUDY CHAIR

• Michel Untereiner, MD

  Centre Francois Baclesse

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: August 1, 2017
• Study Start: October 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

LU (1)