Clinical trial NCT01851018: Toxicity Comparison Between Hypofractionated Radiotherapy With HDR Brachytherapy Boost Versus Standard Treatment
Official title: Match Pair Analysis Study, Comparing Toxicities Between 2 Treatment Regiments Including Neo-adjuvant Hormonal Therapy Plus Hypofractionated RT With HDR Brachytherapy Boost Compare to Our Current Clinical Standard Approach at CHU de Quebec
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
brachytherapy
hypofractionated radiation therapy
hormonal therapy
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2013-05-10
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Radiation (hypo fractionation)
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare toxicities between 2 external beam radiation fractionation schemes plus a brachytherapy boost for prostate cancer. Our current standard use a 2 Gy per fraction schedule which is compare to the experimental hypofractionated 3 Gy per day approach with neo adjuvant hormonal therapy. It will demonstrate the feasibility and safety of such a treatment regimen in prostate cancer. It may also set base for a larger randomized trial.

Detailed description: 30 patients with intermediate / extensive low risk (all core biopsies involvements \> 50%) prostate cancer (not necessitating to treat the nodal regions) will be included in this study. Patient stage T1 - T2, Gleason score ≤ 7, prostate-specific antigen (PSA) ≤ 20 will be considered.

Fiducial gold markers will be introduced in the prostate 1-week before the CT planning. 36 gray (Gy) in 12 fractions using intensity-modulated radiation therapy (IMRT) will be administered to the prostate (margins of 0,5cm) +/- first centimeter of the seminal vesicles.

Brachytherapy boost (15 Gy x 1) dosimetric parameters should respect our current standard (Prostate V100 \> 90% and V150 ≤ 40%, V200 ≤ 15%, Urethra V125 ≤ 1 cc, Rectum V75 ≤ 1cc, Bladder V75 ≤ 1cc). Short course (4 months) hormonal therapy (Degarelix) will be administered to the patient based upon recommended litterature11, 12.

Genitourinary (GU), GI and Sexual toxicity will be self reported. QOL questionnaires will be given to the patients to be answered. Results will be monitored and compared to our currently used standard fractionation regiment.

Follow-up will be scheduled 6 weeks after the implant and every 4 months for the first year, every 6 months for the second year 2 to 5, and on a yearly basis after 5 years. PSA \& testosterone tests will be done every 3 months for the first 3 years, every 6 months on years 4 and 5, and yearly thereafter.

Eligibility criteria: Inclusion Criteria:

* 30 patients
* intermediate / extensive low risk (all core biopsies involvements \> 50%)
* prostate cancer (not necessitating to treat the nodal regions)
* Patient stage T1 - T2,
* Gleason score ≤ 7,
* PSA ≤ 20 will be considered

Exclusion Criteria:

* patient unfit for biopsy or brachytherapy
* high or low risk prostate cancer

Primary outcomes:
measure: Evaluate and compare toxicity changes through follow-up between our study population and a reference group in regards to Median international prostate symptoms scores (IPSS).
timeFrame: baseline, 6 weeks post-implant, and at 4,8,12 months
measure: Evaluate and compare toxicity changes through follow-up between our study population and a reference group in regards to gastro-intestinal (GI) toxicity score.
timeFrame: baseline, 6 weeks post-implant, and at 4,8,12 months
measure: Evaluate and compare toxicity changes through follow-up between our study population and a reference group in regards to Sexual toxicity (EPIC or SHIM) score.
timeFrame: baseline, 6 weeks post-implant, and at 4,8,12 months
Secondary outcomes:
measure: Evaluate and compare biochemical disease free survival being non inferior to comparative cohort
timeFrame: 5 years
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: CHUdeQuebec
Study officials:
affiliation: CHUQ L'Hotel Dieu de Quebec
name: Andre-Guy Martin, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Bari B, Daidone A, Alongi F. Is high dose rate brachytherapy reliable and effective treatment for prostate cancer patients? A review of the literature. Crit Rev Oncol Hematol. 2015 Jun;94(3):360-70. doi: 10.1016/j.critrevonc.2015.02.003. Epub 2015 Feb 17.