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

NCT01851018 | Active Not Recruiting

• 2 other identifiers: H12-03-90HYBRAFI
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; brachytherapy; hypofractionated radiation therapy; hormonal therapy

Outcome Measures

Primary Outcomes (3)

• 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).

  Comparison of the patient reported IPSS scores through the follow-up between each treatment group.

  baseline, 6 weeks post-implant, and at 4,8,12 months

• Evaluate and compare toxicity changes through follow-up between our study population and a reference group in regards to gastro-intestinal (GI) toxicity score.

  Comparison of the patient reported Gastro-intestinal toxicity scores through the follow-up between each treatment group.

  baseline, 6 weeks post-implant, and at 4,8,12 months

• 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.

  Comparison of the patient reported Sexual toxicity (EPIC or SHIM) scores through the follow-up between each treatment group.

  baseline, 6 weeks post-implant, and at 4,8,12 months

Secondary Outcomes (1)

• Evaluate and compare biochemical disease free survival being non inferior to comparative cohort

  5 years

Study Arms (2)

Hypofraction

EXPERIMENTAL

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

Standard

ACTIVE COMPARATOR

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

Interventions

Hypofraction RADIATION

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).

Hypofraction

Standard RADIATION

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

Standard

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

CHUdeQuebec

Québec, G1R 2J6, Canada

Location

Related Publications (1)

• 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.

  PMID: 25819287 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Andre-Guy Martin, MD MSc

  CHUQ L'Hotel Dieu de Quebec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: André-Guy Martin MD MSC FRCP(C) Radio-oncologue, Curiethérapeute Professeur Associé, Université Laval, L'Hôtel-Dieu de Québec du CHUQ

Model Details: Radiation (hypo fractionation)

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: May 10, 2013
• Study Start: May 1, 2012
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

CA (1)