Actively Recruiting
Highly Metastatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases
Led by Institut Cancerologie de l'Ouest · Updated on 2026-06-04
18
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the maximum tolerated volume (MTV) of metastatic lesions in patients with high-volume metastatic prostate cancer that is resistant to therapy. This phase 1 study focuses on bone and lymph node metastases in patients whose cancer has progressed after androgen-receptor pathway inhibitors, chemotherapy, or other life-prolonging treatments. The goal is to determine how much tumor volume can be safely treated with stereotactic radiotherapy (SRT) to potentially extend the time without pain or tumor complications. Participants will receive stereotactic body radiotherapy (SBRT) targeting a subset of metastatic lesions prioritized by risk of causing pain or complications like fractures or spinal compression. The radiation dose regimens are 27 Gy over 3 fractions or 35 Gy over 5 fractions, spaced with at least 24 hours between sessions. The treatment volume will be escalated progressively until the maximum tolerated volume is reached, based on bone marrow reserve and tumor volume ratios. During the study, participants will undergo assessments including pain evaluation using the EVA scale, monitoring for radiotherapy-related toxicities, and tracking tumor-related complications or death for up to two years. Researchers will also determine the recommended irradiation volume for future studies. The total study duration includes a 12-week evaluation of MTV and extended follow-up for safety and clinical outcomes. Participants must comply with scheduled visits and examinations throughout the trial.
CONDITIONS
Brief Title
HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases (HIMARS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic prostate cancer with clinical progression after androgen-receptor pathway inhibitor, chemotherapy, or other life-prolonging therapy
- Performance status less than 3
- Bone and/or lymph node metastases detected by conventional or metabolic imaging
- Metastases suitable for stereotactic radiotherapy as assessed by investigator
- Adequate organ function with ANC ≥ 1000/mm3, platelet count ≥ 50,000/mm3, or hemoglobin ≥ 8 g/dL
- Age 18 years or older at study entry
- Written informed consent obtained
- Willing and able to comply with study protocol and visits
- Valid health insurance
- Life expectancy greater than 3 months
You will not qualify if you...
- Symptomatic metastases in lungs, brain, peritoneum, or liver
- Diffuse metastatic spread to bone marrow or cerebrospinal fluid
- Symptomatic spinal cord compression requiring neurosurgical decompression
- High-risk tumor volume to bone marrow reserve ratio > 50%
- Concurrent participation in another therapeutic clinical study
- Mental impairment affecting consent or compliance
- Legal guardianship or loss of freedom
- Unable to follow medical follow-up due to social, geographical, or psychological reasons
- History of other primary malignancy unless treated with curative intent and no active disease for over 2 years
- Uncontrolled pain preventing positioning for radiotherapy
- Current or indicated cytopenic treatments like chemotherapy or RadioLigand Therapy
- Concurrent treatments that may cause severe gastrointestinal or genitourinary disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants receive stereotactic body radiotherapy (SBRT) targeting bone and lymph node metastases with specific dosing regimens delivered over several fractions.
3 to 5 visits over 1 to 2 weeks depending on the fractionation schedule
Duration - Up to 2 years
Participants are monitored for treatment toxicity, pain relief, and tumor-related complications after completing radiotherapy.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
ICO
Saint-Herblain, France, 44805
Actively Recruiting
Research Team
L
Loïg Vaugier, MD
L
Lucie Labarre
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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