BridgeMD
New treatment option for Prostate Cancer Metastatic Disease
Official title HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases (HIMARS)
ClinicalTrials.gov ID: NCT06978296
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Metastatic prostate cancer with clinical progression after the use of androgen-receptor pathway inhibitor, chemotherapy or any other life-prolonging...
- 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:
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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
- 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
- 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;
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Saint-Herblain, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint-Herblain, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.