Ultra-hypofractionated radiotherapy combined with HDR brachytherapy: An optimized treatment.
I Sidibé, M M Beaudry, D Carignan...
https://pubmed.ncbi.nlm.nih.gov/41067642Actively Recruiting
Phase 2
Phase 3
Age: 18Years +
MALE
ID07426055
PRO-BOOST-LC: Comparing Whole-Gland Radiation Boost Using HDR Brachytherapy, LDR Brachytherapy, or Single-Fraction SBRT After Ultrahypofractionated EBRT Versus SBRT Monotherapy in Localized and Locally Advanced Prostate Cancer Staged by PSMA PET/CT
Led by Affidea Nu-med Center of Oncological DIagnostics and Therapy · Updated on 2026-03-23
1200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different radiation dose escalation strategies for men with localized or locally advanced prostate cancer that has been confirmed not to have spread to lymph nodes or distant sites using modern PSMA PET imaging. This trial compares established approaches including stereotactic body radiotherapy (SBRT) alone versus SBRT combined with a focused radiation boost using high-dose-rate (HDR) brachytherapy, low-dose-rate (LDR) brachytherapy, or an additional SBRT boost. The goal is to find the best balance between cancer control, treatment side effects, and quality of life using modern imaging and precise radiation techniques. Participants are randomly assigned to one of four groups: SBRT monotherapy, or a standardized ultrahypofractionated external beam radiotherapy (EBRT) backbone followed by either HDR brachytherapy boost, LDR brachytherapy boost, or a single-fraction SBRT boost. Treatments use image-guided technology and follow strict protocol guidelines to ensure consistent delivery while protecting healthy organs. Androgen deprivation therapy (ADT) is given according to current clinical guidelines based on risk. The study incorporates an initial safety phase and continues into a confirmatory phase with monitoring for toxicity and treatment feasibility. During the study, participants undergo thorough assessments including clinical exams, blood tests such as PSA, imaging with PSMA PET/CT and multiparametric MRI, and standardized surveys on urinary, bowel, sexual function, and overall quality of life. Follow-up visits occur regularly to monitor side effects, disease status, and patient-reported outcomes for up to 10 years. The primary outcome is failure-free survival, including cancer recurrence and need for further treatment. Secondary outcomes include metastasis-free survival, toxicity, quality of life, and overall survival. This long-term follow-up aims to provide high-quality evidence to guide future treatment decisions for prostate cancer patients.
CONDITIONS
Brief Title
PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 years or older
- Histologically confirmed adenocarcinoma of the prostate
- Localized or locally advanced prostate cancer classified as cT1-4, cN0, cM0
- Negative pelvic nodal and distant metastatic disease on baseline PSMA PET
- NCCN favorable or unfavorable intermediate-, high-, or very high-risk disease
- Candidate for definitive radiotherapy with curative intent
- ECOG performance status 0-2
- Baseline PSA available prior to randomization
- Ability to undergo external beam radiotherapy and brachytherapy or SBRT as per protocol
- Planned androgen deprivation therapy permitted according to risk group
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Evidence of pelvic nodal (cN1) or distant metastatic disease (cM1) on baseline imaging
- Prior definitive local treatment for prostate cancer, including prostatectomy, brachytherapy, or external beam radiotherapy
- Prior pelvic radiotherapy for any malignancy
- Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant ADT
- History of other active malignancy requiring systemic treatment (except adequately treated non-melanoma skin cancer)
- Contraindications to radiotherapy or anesthesia required for brachytherapy
- Severe uncontrolled comorbidities precluding protocol treatment
- Inability to comply with study procedures or follow-up schedule
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)
Treatment
Duration - Approximately 1 to 2 weeks
Participants receive either stereotactic body radiotherapy (SBRT) monotherapy or ultrahypofractionated external beam radiotherapy (EBRT) followed by a whole-gland boost using high-dose-rate brachytherapy, low-dose-rate brachytherapy, or SBRT boost according to their assigned treatment arm. Androgen deprivation therapy may be administered according to risk group and clinical guidelines. All treatments are delivered with curative intent using image-guided techniques.
5 treatment visits for EBRT or SBRT fractions plus 1 to 2 additional visits for boost procedures depending on assigned arm
Follow-up
Duration - Up to 10 years
Participants are monitored for disease control, treatment-related toxicity, and quality of life with regular assessments including imaging, laboratory tests, and patient-reported outcomes for up to 10 years after treatment.
Regular follow-up visits scheduled according to protocol over 10 years
Trial Site Locations
Total: 1 location
1
Affidea Nu-Med, Center of Oncological Diagnostics and Therapy
Zamość, Lublin Voivodeship, Poland, 22-400
Actively Recruiting
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Research Team
M
Mateusz Edward Bilski, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Lucas C Mendez, Juanita Crook, Kevin Martell...
https://pubmed.ncbi.nlm.nih.gov/38072323Comparison of four-year toxicities and local control of ultra-hypofractionated vs moderate-hypofractionated image guided prostate radiation with HDR brachytherapy boost: A phase I-II single institution trial.
M M Beaudry, D Carignan, W Foster...
https://pubmed.ncbi.nlm.nih.gov/36875870Early outcomes of high-dose-rate brachytherapy combined with ultra-hypofractionated radiation in higher-risk prostate cancer.
Daniel Gorovets, Margaret Hopkins, Marisa Kollmeier...
https://pubmed.ncbi.nlm.nih.gov/34588146Combined brachytherapy and ultra-hypofractionated radiotherapy for intermediate-risk prostate cancer: Comparison of toxicity outcomes using a high-dose-rate (HDR) versus low-dose-rate (LDR) brachytherapy boost.
Marisa A Kollmeier, Daniel Gorovets, Jessica Flynn...
https://pubmed.ncbi.nlm.nih.gov/35725549TROG 18.01 phase III randomised clinical trial of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation: NINJA study protocol.
Jarad Martin, Paul Keall, Shankar Siva...
https://pubmed.ncbi.nlm.nih.gov/31434782Whole Pelvic Radiotherapy With Stereotactic Body Radiotherapy Boost vs. Conventionally Fractionated Radiotherapy for Patients With High or Very High-Risk Prostate Cancer.
Shih-Chang Wang, Wei-Chen Ting, Yun-Ching Chang...
https://pubmed.ncbi.nlm.nih.gov/32547949High-risk prostate cancer treated with a stereotactic body radiation therapy boost following pelvic nodal irradiation.
Jonathan W Lischalk, Meredith Akerman, Michael C Repka...
https://pubmed.ncbi.nlm.nih.gov/38410097Prostate Virtual High-dose-rate Brachytherapy Boost: 5-Year Results from the PROMETHEUS Prospective Multicentre Trial.
Eric Wegener, Mark Sidhom, David Pryor...
https://pubmed.ncbi.nlm.nih.gov/38302321MUlticentre REtrospective comparison of definitive EBRT with or without HDR BRAchytherapy boost in patients with locally-advanced prostate cancer and regional lymph NOde metastases (MUREBRANO) - A propensity score matched analysis.
Mateusz Bilski, Piotr Lelek, Magdalena Stankiewicz...
https://pubmed.ncbi.nlm.nih.gov/40882818