Fractured Spine Clinical Trials

Find Fractured Spine Clinical Trials Near You

HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

⁃ 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

Locations
Other Locations
France
ICO
RECRUITING
Saint-herblain
Contact Information
Primary
Loïg Vaugier, MD
loig.vaugier@ico.unicancer.fr
+33240679900
Backup
Lucie Labarre
lucie.labarre@ico.unicancer.fr
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2030-07-01
Participants
Target number of participants: 18
Treatments
Experimental: stereotaxic radiotherapy
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%
Related Therapeutic Areas
Sponsors
Leads: Institut Cancerologie de l'Ouest

This content was sourced from clinicaltrials.gov