SRT for bone and lymph node metastases in advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study uses a dose‑escalation approach to define the maximum total volume of metastases that can be safely treated with stereotactic radiotherapy (SRT) in patients with bone or lymph node metastases. Participants have castration‑resistant or chemo‑refractory disease and have progressed after other life‑prolonging therapies. The trial targets lesions at higher risk of pain or compression and gradually expands the irradiated volume to determine MTV. Primary focus is on safety and tolerability, with secondary observations on pain, tumor control, and complication rates. SBRT is delivered to selected metastatic sites, with careful monitoring for adverse effects and treatment‑related events.

Why it matters

Who can join: the full rules

Inclusion 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 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:

  1. Absolute Neutrophil Count (ANC) ≥ 1000/mm3 or
  2. Platelet Count ≥ 50 000/mm3 or
  3. 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

Exclusion Criteria:

* 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

  1. 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
  2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  3. 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

Where it's running

• Ico
  Saint-Herblain, France Recruiting

Study contacts

• Principal investigator: Loïg Vaugier, MD — Ico
• Study coordinator: Loïg Vaugier, MD
• Email: loig.vaugier@ico.unicancer.fr
• Phone: +33240679900

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JUR-003 in adults with advanced prostate cancer

  This first-in-human study tests JUR-003 to see if it is safe and tolerable and to get an early sense of activity in adults with metastatic or advanced prostate cancer.

  Recruiting at 4 sites Phase 1 TCG Labs Soleil · Grand Rapids, Michigan and 3 other locations · NCT07824349

• PSMA-targeted fluorescent dye OTL78 to guide prostate cancer surgery

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• Using PSMA PET with MRI to watch for prostate cancer returning after focal therapy

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• DNA vaccine plus nivolumab and targeted radiation for recurrent oligometastatic prostate cancer

  This study will try a DNA vaccine called pTVG-HP together with the checkpoint blocker nivolumab and targeted radiation to see if they can eliminate metastatic tumors in men with non-castrate, recurrent oligometastatic prostate cancer.

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• Mini-tumors to guide treatment for aggressive prostate cancer

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• Combining radiotherapy or surgery with intense hormone therapy for advanced prostate cancer

  This study is testing if combining surgery or radiation with strong hormone therapy can help men with newly diagnosed advanced prostate cancer feel better and live longer.

  Recruiting Phase 2 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT06992232

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.