Prostate Cancer Metastatic DiseaseHIMARSNCT06978296
HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases (HIMARS)
A study testing Stereotactic body radiotherapy (SBRT) in people with Prostate Cancer Metastatic Disease and Oligometastatic Prostate Cancer (OMPC), run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
The investigators propose redefining this concept by focusing on volume rather than the number of metastases. To achieve this, the investigators aim to determine the Maximum Tolerated Volume (MTV) of metastatic lesions treatable with SRT (Stereotaxic radiotherapy) in a phase 1 study. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic Disease, Oligometastatic Prostate Cancer (OMPC)
- What is being tested?
- Stereotactic body radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 1 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic prostate cancer with clinical progression after the use of androgen-receptor pathway inhibitor, chemotherapy or any other life-prolonging therapy. Patient could have been treated previously by RadioLigand Therapy (RLT).
- Performance Status < 3
- Bone and/or lymph node metastases based on conventional (CT and bone scan) or metabolic imaging
- Bone and/or lymph node metastases suitable for SRT, according to the investigator
- Adequate organ function:
- Absolute Neutrophil Count (ANC) ≥ 1000/mm3 or
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- Platelet Count ≥ 50 000/mm3 or
- Haemoglobin ≥ 8 g/dL (allowing transfusion or other intervention to achieve this minimum haemoglobin)
- Age ≥ 18 years at time of study entry
- Written informed consent obtained from the patient prior to performing any protocol-related
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Patient has valid health insurance
- Life time expected > 3 months
Who cannot join
- Evidence of symptomatic metastases to the lungs, brain, peritoneum or liver
- Evidence of diffuse metastatic spread to the bone marrow (e.g. positive super bone scan) or the cerebral spinal fluid as per bone scan (no lumbar puncture required).
- Evidence of presence of symptomatic spinal cord compression with indication of neurosurgical decompression.
- Patient with symptomatic and/or high-risk tumor volume-to-bone marrow reserve ratio > 50%
- Concurrent enrolment in another clinical study, unless it is a non-therapeutic clinical study
- Mental impairment (psychiatric illness/social situations) that may compromise the ability of the patient to give informed consent and comply with the requirements of the study;
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- Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship;
- Patients unable to undergo medical follow-up in the study for geographical, social or psychological reasons.
- History of another primary malignancy except for
- Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of SRT and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Uncontrolled pain that contraindicates patient positioning on the radiotherapy table according to investigator
- Patient indicated to or currently treated by cytopenic treatment as chemotherapy or RadioLigand Therapy
- Patient under concomitant treatment that may generate severe gastro-intestinal disorder or genito-urinary disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lucie Labarre contact
France1 site, 1 recruiting
- Recruiting
ICO
Saint-Herblain, 44805
Loïg Vaugier, MD, +33240679900, loig.vaugier@ico.unicancer.fr
About this study
Official title: HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases
The investigators propose redefining this concept by focusing on volume rather than the number of metastases. To achieve this, the investigators aim to determine the Maximum Tolerated Volume (MTV) of metastatic lesions treatable with SRT (Stereotaxic radiotherapy) in a phase 1 study. In this study, the investigators will recruit patients with high-volume metastatic disease in bones or lymph nodes and progressively irradiate a volume-escalated subset of the total lesions. The selection will prioritize lesions at higher risk of causing pain or complications, such as fractures, spinal compression, or vascular compression. The investigators hypothesis is that SRT targeting multiple metastases (with a total volume ≤ MTV) will extend the duration without refractory pain and/or tumor-related complications in patients with castration-resistant and chemo-refractory prostate cancer.
- Being tested
- Stereotactic body radiotherapy (SBRT)
- Keywords
- Radiotherapy, Stereotaxic, oligometastatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapy (SBRT)Radiation
The acceptable regimens are:
- 27 Gy / 3 fractions / 3 fractions per week
- 35 Gy / 5 fractions / 3 fractions per week An interval of at least 24 hours should be kept between two consecutive fractions.
Prescription must be defined on 80% isodose or higher, maximum dose up to 130% of the isodose prescription. At least 90% of the Planning Target Volume should receive the prescribed dose. A coverage of <90% of the Planning Target Volume will be considered as acceptable deviation, and coverage of <80% of the target volume as an Unacceptable Deviation. At least 90% of the Gross Tumoral Volume should receive the prescribed dose.
Only a part of the Gross Tumoral Volume_Total could be considered for radiation, depending on the ratio with Bone Marrow Reserve. High-risk and/or symptomatic metastases will be prioritized over other metastases.
Anatomic bone marrow reserve (BMR) will be first determined for each patient:
BMR = Total trabecular bone - (Total trabecular bone ∩ GTV_Total)
| Study group | Role | What they receive |
|---|---|---|
| stereotaxic radiotherapy | Experimental | This volume escalation will be performed until MTV is reached.
Level cohort is defined by: volume level Irradiation volume / Bone Marrow Reserve as below:
level -1: 20% level 1 (start level): 30% level 2: 40% level 3: 50% Receives: Radiation: Stereotactic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated volume (MTV)
The MTV will be defined as the highest volume that can be treated with an acute toxicity of grade < 3 (CTCAE V5.0 scale) in one third of patient and will allow us to determine the recommended phase II volume under the assumption that higher volumes are likely to be more toxic. The maximum tolerated Volume (MTV) is defined as the volume at which 2 Dose-Limiting Toxicity (DLT) were observed among 3 to 6 patients.
DLT are considered as:
- Death clearly related to irradiation
- Intractable pain despite oral or intravenous opioids and/or corticosteroids (EVA > 4 and increase of 2 from EVA baseline)
- Any new grade ≥ 3 toxicity (CTCAE V5.0 scale) compared to baseline among:
- Anemia
- Febrile Neutropenia
- Hemorrhage within grade ≥3 thrombocytopenia
- Any gastro-intestinal-related disorder
- Any genito-urinary-related disorder
- Pneumonitis Bone marrow reserve will be determined by CT-base automatic tool.
Measured: 12 weeks
Secondary outcomes (5)
Number of toxicity related to radiotherapy as assessed by CTCAE v5.0
Acute (≤ 12 weeks) and late (>12 weeks) toxicity will be evaluated according to NCI-CTCAE v5 grading
Measured: through study completion
Recommended volume for irradiation by SRT for phase-II
The Recommended Volume (RV) corresponds to the volume of the level immediately below the MTV. This Recommended Volume for irradiation by SRT will then be applied for phase 2.
Measured: 12 weeks
Pain relief assessed by EVA scale
Global pain evaluation (EVA) will be measured at baseline, 1-, 3- and 6-month following SRT. Score is 0 (no pain) to 10 (maximal pain)
Measured: 6 months
Time to first pejorative event among tumour-related complication (bone, neurological or vascular compression) and/or death
Time to first worsening event due to tumor progression (as seen on thoraco-abdomino-pelvic CT scan): including bone displacement, spinal cord or neurological compression, and vasculo-lymphatic compression will be assessed.
Measured: 2 years
Number of deceased patients
Overall survival is defined as the time interval between the date of registration and the date of death irrespective of the cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jun 2026
- Primary completion1 May 2028 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Metastatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a monocentric prospective level volume escalation phase I study of radiotherapy on oligometastasis.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loïg Vaugier, MD, Principal investigator, ICO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978296
- Sponsor's protocol ID
- ICO-2024-22
- Acronym
- HIMARS
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases
- ClinicalTrials.gov ID
- NCT06978296
- Acronym / sponsor ID
- HIMARS / ICO-2024-22
- Keywords
- Radiotherapy, Stereotaxic, oligometastatic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose redefining this concept by focusing on volume rather than the number of metastases. To achieve this, the investigators aim to determine the Maximum Tolerated Volume (MTV) of metastatic lesions treatable with SRT (Stereotaxic radiotherapy) in a phase 1 study. In this study, the investigators will recruit patients with high-volume metastatic disease in bones or lymph nodes and progressively irradiate a volume-escalated subset of the total lesions. The selection will prioritize lesions at higher risk of causing pain or complications, such as fractures, spinal compression, or vascular compression. The investigators hypothesis is that SRT targeting multiple metastases (with a total volume ≤ MTV) will extend the duration without refractory pain and/or tumor-related complications in patients with castration-resistant and chemo-refractory prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a monocentric prospective level volume escalation phase I study of radiotherapy on oligometastasis.
| Arm | Type | Receives |
|---|---|---|
| stereotaxic radiotherapy | Experimental | Radiation: Stereotactic body radiotherapy (SBRT)This volume escalation will be performed until MTV is reached. Level cohort is defined by: volume level Irradiation volume / Bone Marrow Reserve as below: level -1: 20% level 1 (start level): 30% level 2: 40% level 3: 50% |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Metastatic prostate cancer with clinical progression after the use of androgen-receptor pathway inhibitor, chemotherapy or any other life-prolonging therapy. Patient could have been treated previously by RadioLigand Therapy (RLT).
- Performance Status < 3
- Bone and/or lymph node metastases based on conventional (CT and bone scan) or metabolic imaging
- Bone and/or lymph node metastases suitable for SRT, according to the investigator
- Adequate organ function:
Key exclusion criteria (15 listed)
- Evidence of symptomatic metastases to the lungs, brain, peritoneum or liver
- Evidence of diffuse metastatic spread to the bone marrow (e.g. positive super bone scan) or the cerebral spinal fluid as per bone scan (no lumbar puncture required).
- Evidence of presence of symptomatic spinal cord compression with indication of neurosurgical decompression.
- Patient with symptomatic and/or high-risk tumor volume-to-bone marrow reserve ratio > 50%
- Concurrent enrolment in another clinical study, unless it is a non-therapeutic clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiotherapy (SBRT)The acceptable regimens are: * 27 Gy / 3 fractions / 3 fractions per week * 35 Gy / 5 fractions / 3 fractions per week An interval of at least 24 hours should be kept between two consecutive fractions. Prescription must be defined on 80% isodose or higher, maximum dose up to 130% of the isodose prescription. At least 90% of the Planning Target Volume should receive the prescribed dose. A coverage of <90% of the Planning Target Volume will be considered as acceptable deviation, and coverage of <80% of the target volume as an Unacceptable Deviation. At least 90% of the Gross Tumoral Volume should receive the prescribed dose. Only a part of the Gross Tumoral Volume_Total could be considered for radiation, depending on the ratio with Bone Marrow Reserve. High-risk and/or symptomatic metastases will be prioritized over other metastases. Anatomic bone marrow reserve (BMR) will be first determined for each patient: BMR = Total trabecular bone - (Total trabecular bone ∩ GTV_Total) | Radiation | stereotaxic radiotherapy |
Primary outcome
Maximum tolerated volume (MTV)
Time frame: 12 weeks
The MTV will be defined as the highest volume that can be treated with an acute toxicity of grade < 3 (CTCAE V5.0 scale) in one third of patient and will allow us to determine the recommended phase II volume under the assumption that higher volumes are likely to be more toxic. The maximum tolerated Volume (MTV) is defined as the volume at which 2 Dose-Limiting Toxicity (DLT) were observed among 3 to 6 patients. DLT are considered as: * Death clearly related to irradiation * Intractable pain despite oral or intravenous opioids and/or corticosteroids (EVA > 4 and increase of 2 from EVA baseline) * Any new grade ≥ 3 toxicity (CTCAE V5.0 scale) compared to baseline among: * Anemia * Febrile Neutropenia * Hemorrhage within grade ≥3 thrombocytopenia * Any gastro-intestinal-related disorder * Any genito-urinary-related disorder * Pneumonitis Bone marrow reserve will be determined by CT-base automatic tool.
5 secondary outcomes
Number of toxicity related to radiotherapy as assessed by CTCAE v5.0
Time frame: through study completion
Recommended volume for irradiation by SRT for phase-II
Time frame: 12 weeks
Pain relief assessed by EVA scale
Time frame: 6 months
Time to first pejorative event among tumour-related complication (bone, neurological or vascular compression) and/or death
Time frame: 2 years
Number of deceased patients
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer Metastatic Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucie Labarre contact
Loïg Vaugier, MD principal investigator
ICO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body radiotherapy (SBRT) in people with Prostate Cancer Metastatic Disease and Oligometastatic Prostate Cancer (OMPC), run by Institut Cancerologie de l'Ouest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Loïg Vaugier, MD (+33240679900, loig.vaugier@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated volume (MTV) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.