Comparison of health-related quality of life 5 years after SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial.
Juanita Mary Crook, Alfonso Gomez-Iturriaga, Kris Wallace...
https://pubmed.ncbi.nlm.nih.gov/21149658Actively Recruiting
Phase Not Applicable
Age: 18Years - 95Years
MALE
Healthy Volunteers
ID05786742
ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.
Led by CHU de Quebec-Universite Laval · Updated on 2025-09-09
205
Participants Needed
1
Research Sites
391 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two types of radiation therapy for men with localized prostate adenocarcinoma: ultra-hypofractionated (UH) therapy and moderately hypofractionated (MH) therapy, combined with image-guided high-dose-rate (HDR) prostate brachytherapy. The study aims to compare the side effects and tolerability of these radiation approaches and assess if UH therapy is not worse than MH therapy in terms of toxicity. The study also involves outlining MRI-visible dominant intra-prostatic lesions and examining variability between radiation oncologists and radiologists. Secondary goals include monitoring biochemical and clinical failure-free survival at 5 and 10 years. The trial includes two treatment groups: one receiving UH radiation therapy delivering 25 Gy in 5 fractions over 7 days, targeting the prostate and the first centimeter of the seminal vesicle; the other receiving MH radiation therapy delivering 37.5 Gy in 15 fractions or 36 Gy in 12 fractions over several weeks. All participants receive HDR brachytherapy with a single 15 Gy fraction under anesthesia, involving catheter and marker placement for precise treatment delivery. Imaging such as TRUS, CT scans, and multiparametric MRI are used for planning and monitoring. Treatment techniques include IMRT, VMAT, or SBRT, with dosimetric optimization and live dose monitoring in some patients. Participants undergo regular evaluations including toxicity assessments using CTCAE version 5, urinary symptom scoring (IPSS), sexual function questionnaires (SHIM), and quality of life surveys (EPIC-26) starting before treatment and continuing up to 5 years post-therapy. Clinical outcomes and biochemical failure rates are also tracked at 5 and 10 years. Safety and side effects are monitored carefully at multiple time points, with imaging and laboratory data collected before and after treatment. The study lasts several years to capture both acute and late effects of the therapies.
CONDITIONS
Brief Title
Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.
Who Can Participate
Age: 18Years - 95Years
MALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Biopsy proven Prostate adenocarcinoma
- Clinical stage T1c or T2
- Stage Nx or N0
- Stage Mx or M0
- PSA less than 20 ng/ml
- Gleason Score 6 or 7
- Ability to sign a written consent
You will not qualify if you...
- Age under 18 years
- Clinical stage T3 or T4
- Stage N1
- Stage M1
- PSA greater than 20 ng/ml
- Gleason Score 8 to 10
- IPSS Score greater than 20 despite alpha-blocking medication
- Prior pelvic radiotherapy
- History of active collagenosis (Lupus, Sclerodermia, Dermatomyosis)
- Past history of Inflammatory Bowel Disease
- Bilateral hip prosthesis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Implantation and Planning
Duration - 1 to 2 days
Participants undergo implantation of prostate brachytherapy catheters under anesthesia, followed by imaging and treatment planning before radiotherapy.
1 to 2 visits including implantation and planning imaging
Treatment
Duration - 1 to 3 weeks depending on treatment arm
Participants receive either ultra hypofractionated or moderate hypofractionated radiotherapy combined with a high-dose-rate brachytherapy boost to the prostate and seminal vesicles.
5 radiotherapy fractions over approximately 7 days or 12 to 15 daily fractions over 2 to 3 weeks
Follow-up Monitoring
Duration - Up to 5 years post-therapy
Participants are monitored for toxicity, urinary symptoms, sexual function, and quality of life through regular assessments up to 5 years post-treatment.
Visits at 3 months, 6 months, 1 year, then yearly up to 5 years
Trial Site Locations
Total: 1 location
1
CHUdeQuebec
Québec, Canada, G1R 2J6
Actively Recruiting
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Research Team
A
Andre-Guy Martin
J
Josee Allard
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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An eight-year experience of HDR brachytherapy boost for localized prostate cancer: biopsy and PSA outcome.
François Bachand, André-Guy Martin, Luc Beaulieu...
https://pubmed.ncbi.nlm.nih.gov/18963537Comparative analysis of prostate-specific antigen free survival outcomes for patients with low, intermediate and high risk prostate cancer treatment by radical therapy. Results from the Prostate Cancer Results Study Group.
Peter Grimm, Ignace Billiet, David Bostwick...
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W J Morris, M Keyes, D Palma...
https://pubmed.ncbi.nlm.nih.gov/19168203Population-based 10-year oncologic outcomes after low-dose-rate brachytherapy for low-risk and intermediate-risk prostate cancer.
W James Morris, Mira Keyes, Ingrid Spadinger...
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Gerard Morton, Andrew Loblaw, Patrick Cheung...
https://pubmed.ncbi.nlm.nih.gov/21924511Surgical management of prostate cancer.
Jonathan L Wright, Jason P Izard, Daniel W Lin
https://pubmed.ncbi.nlm.nih.gov/24188255Local control following permanent prostate brachytherapy: effect of high biologically effective dose on biopsy results and oncologic outcomes.
Nelson N Stone, Richard G Stock, Jamie A Cesaretti...
https://pubmed.ncbi.nlm.nih.gov/19632069Higher-than-conventional radiation doses in localized prostate cancer treatment: a meta-analysis of randomized, controlled trials.
Gustavo Arruda Viani, Eduardo Jose Stefano, Sergio Luis Afonso
https://pubmed.ncbi.nlm.nih.gov/19616743Ultrasonically guided precise needle placement in the prostate and the seminal vesicles.
H H Holm, J Gammelgaard
https://pubmed.ncbi.nlm.nih.gov/7206090