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Toxicity Comparison Between Hypofractionated Radiotherapy With HDR Brachytherapy Boost Versus Standard Treatment (HyBraFi)

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ClinicalTrials.gov Identifier: NCT01851018
Recruitment Status : Unknown
Verified May 2013 by André-Guy Martin, CHU de Quebec-Universite Laval.
Recruitment status was:  Active, not recruiting
First Posted : May 10, 2013
Last Update Posted : May 10, 2013
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
André-Guy Martin, CHU de Quebec-Universite Laval

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Hypofraction Radiation: Standard Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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 Start Date : May 2012
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Hypofraction
Patient reported toxicities related to Hypofraction radiation treatment (3 Gy daily, 5 fractions per week) up to a total of 36 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant firmagon (240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL as a starting dose with a maintenance dose of 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL administered every 28 days).
Radiation: Hypofraction
Patient reported toxicities related to Hypofraction radiation treatment (3 Gy daily, 5 fractions per week) up to a total of 36 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant firmagon (240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL as a starting dose with a maintenance dose of 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL administered every 28 days).

Active Comparator: Standard
Patient reported toxicities related to the Standard radiation treatment (2 Gy daily, 5 fractions per week) up to a total of 44 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant LHRH agonists.
Radiation: Standard
Patient reported toxicities related to the Standard radiation treatment (2 Gy daily, 5 fractions per week) up to a total of 44 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant LHRH agonists




Primary Outcome Measures :
  1. 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). [ Time Frame: baseline, 6 weeks post-implant, and at 4,8,12 months ]
    Comparison of the patient reported IPSS scores through the follow-up between each treatment group.

  2. Evaluate and compare toxicity changes through follow-up between our study population and a reference group in regards to gastro-intestinal (GI) toxicity score. [ Time Frame: baseline, 6 weeks post-implant, and at 4,8,12 months ]
    Comparison of the patient reported Gastro-intestinal toxicity scores through the follow-up between each treatment group.

  3. 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. [ Time Frame: baseline, 6 weeks post-implant, and at 4,8,12 months ]
    Comparison of the patient reported Sexual toxicity (EPIC or SHIM) scores through the follow-up between each treatment group.


Secondary Outcome Measures :
  1. Evaluate and compare biochemical disease free survival being non inferior to comparative cohort [ Time Frame: 5 years ]
    biochemical disease free survival (Phoenix definition)



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851018


Locations
Canada
CHUdeQuebec
Quebec, Canada, G1R 2J6
CHUQ L'Hotel-Dieu de Quebec
Quebec, Canada, G1R 2J6
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Ferring Pharmaceuticals
Investigators
Principal Investigator: Andre-Guy Martin, MD MSc CHUQ L'Hotel Dieu de Quebec

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: André-Guy Martin, André-Guy Martin MD MSC FRCP(C) Radio-oncologue, Curiethérapeute Professeur Associé, Université Laval, L'Hôtel-Dieu de Québec du CHUQ, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT01851018     History of Changes
Other Study ID Numbers: H12-03-90
HYBRAFI ( Other Identifier: CHUdeQuebec )
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: May 2013

Keywords provided by André-Guy Martin, CHU de Quebec-Universite Laval:
Prostate cancer
brachytherapy
hypofractionated radiation therapy
hormonal therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases