Early 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/34588146Actively Recruiting
Phase 2
Age: 18Years +
MALE
ID06772441
Personalized Radiotherapy with Androgen Deprivation Therapy for High-Risk Localized Prostate Cancer A Prospective Single-Arm Study Using Artificial Intelligence to Guide Treatment
Led by German Oncology Center, Cyprus · Updated on 2025-01-13
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
G
German Oncology Center, Cyprus
Lead Sponsor
A
Artera
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a personalized treatment approach for men with high-risk localized prostate cancer using advanced artificial intelligence to guide both radiotherapy and androgen deprivation therapy (ADT) durations. This phase II, single-center study focuses on patients classified as low or intermediate risk by the multimodal artificial intelligence (MMAI) classifier and meets National Comprehensive Cancer Network (NCCN) criteria for high-risk prostate cancer. The aim is to improve treatment by escalating the radiation dose directly to the prostate while shortening the usual duration of hormone therapy. Participants will receive a high-dose-rate (HDR) brachytherapy boost to the prostate with a single fraction of 15 Gray (Gy), followed by stereotactic body radiation therapy (SBRT) delivering 25 Gy in five daily fractions to the prostate and seminal vesicles. Alongside radiation, patients will undergo 12 months of androgen deprivation therapy using Goserelin injections, given concurrently and as adjuvant treatment. The treatment schedule includes fiducial marker placement, a 14-day gap, and then five consecutive days of SBRT. Throughout the study, participants will be closely monitored for disease-free survival over five years, along with secondary outcomes such as metastasis-free survival, prostate cancer-specific survival, and overall survival. Assessments will include imaging studies like PSMA-PET and multiparametric MRI, biopsy evaluations, and symptom scoring. Safety and adherence will be tracked, and the study could provide a foundation for future randomized trials comparing this intensified radiotherapy with shorter hormone therapy to current standards. Additionally, the research includes efforts to discover new biomarkers to predict treatment outcomes and impact the socio-economic burden of prostate cancer.
CONDITIONS
Official Title
Artificial Intelligence Driven Personalisation of Radiotherapy and Concomitant Androgen Deprivation Therapy for Prostate Cancer Patients (the HypoPro Trial)
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate (re-biopsy if biopsy older than 12 months should be considered)
- Primary prostate cancer confirmed by PSMA-PET imaging and multiparametric MRI
- High-risk prostate cancer per NCCNv4.2023 criteria (cT3a or Grade group 4-5 or PSA > 20 ng/ml)
- Signed written informed consent for the study
- Age greater than 18 years
- Previous PSMA-PET/CT, multiparametric MRI or PSMA-PET/MR imaging done
- Classified as MMAI low- or intermediate-risk
- ECOG performance status 0 or 1
- IPSS score 15 or less
- Prostate biopsy core with highest ISUP grade available
You will not qualify if you...
- Prior radiotherapy to the prostate or pelvis
- Prior radical prostatectomy
- Prior focal therapy to the prostate
- Evidence of pelvic nodal disease (cN+) on mpMRI or PSMA-PET/CT
- Evidence of distant metastatic disease (cM+) on mpMRI or PSMA-PET/CT
- More than 2 months gap between starting systemic therapy or ADT and PSMA-PET scans
- Evidence of cT4 disease on mpMRI or PSMA-PET/CT
- PSA greater than 50 ng/ml before starting systemic therapy
- Expected survival less than 5 years
- Bilateral hip prostheses or implants causing significant CT artifacts
- Contraindications to MRI or HDR brachytherapy
- Contraindications to Goserelin
- Significant prostate surgery cavity or surgery within 6 months before randomization
- Medical conditions making radiotherapy inadvisable (e.g., acute inflammatory bowel disease, hemiplegia, paraplegia)
- Previous malignancy within 2 years except certain skin cancers or if it affects 5-year survival
- Contraindications to external beam radiotherapy to pelvis
- Participation in other interventional clinical trials within 30 days prior
- Simultaneous participation in interfering interventional trials
- Lack of legal capacity to understand the trial
- Known or persistent substance abuse
- Expected severe setup problems such as mental condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
German Oncology Center
Limassol, Cyprus, 4108
Actively Recruiting
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Research Team
E
Elena Pallari, PhD
K
Kristis Vevis, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Daniel E Spratt, Siyi Tang, Yilun Sun...
https://pubmed.ncbi.nlm.nih.gov/38320143Author Correction: Prostate cancer therapy personalization via multi-modal deep learning on randomized phase III clinical trials.
Andre Esteva, Jean Feng, Douwe van der Wal...
https://pubmed.ncbi.nlm.nih.gov/36813827Focal Boost to the Intraprostatic Tumor in External Beam Radiotherapy for Patients With Localized Prostate Cancer: Results From the FLAME Randomized Phase III Trial.
Linda G W Kerkmeijer, Veerle H Groen, Floris J Pos...
https://pubmed.ncbi.nlm.nih.gov/33471548oDigital pathology biomarkers for guiding radiotherapy-based treatment concepts in prostate cancer - a systematic review and expert consensus.
Constantinos Zamboglou, William De Doncker, Andreas Thomas Christoforou...
https://pubmed.ncbi.nlm.nih.gov/40645505