Clinical trial NCT03235557: CyberKnife for Prostate Cancer Patients Aged 70 y or More
Official title: Robotic Radiation Treatment of Prostate Cancer Patients Aged 70 y or More
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate
cancer
radiation
stereotactic
CyberKnife
elderly
Lead sponsor: Centre Francois Baclesse, Luxembourg
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 150
Sex: MALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients suffering prostatic adenocarcinoma

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute and late toxicity (Using the CTCAEv4)
timeFrame: During 36 months after treatment
Secondary outcomes:
measure: PSA evaluation
timeFrame: at 4 and 6 months, than every 6 months for 3 years
measure: Digital rectal exam
timeFrame: at 6, 12, 24 and 36 months
measure: Birads score evaluation
timeFrame: at 36 months
measure: IPSS evaluation
timeFrame: at 12, 24 and 36 months
measure: IIEF5 evaluation
timeFrame: at 12, 24 and 36 months
Other outcomes:
Locations:
city: Esch Sur Alzette
country: Luxembourg
facility: Centre Francois Baclesse
Study officials:
affiliation: Centre Francois Baclesse
name: Philippe Nickers, MD, PhD
role: STUDY_CHAIR
affiliation: Centre Francois Baclesse
name: Michel Untereiner, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
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.