Combining radiation therapy with hormone treatment for 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 clinical trial investigates the effectiveness of stereotactic body radiation therapy (SBRT) combined with standard care for patients with castration-sensitive oligometastatic prostate cancer. A total of 266 patients will be enrolled, who will undergo screening to confirm their eligibility based on the number of metastatic lesions. Participants will be randomly assigned to receive either SBRT plus standard care or standard care alone. The study aims to evaluate the potential benefits of adding SBRT to the treatment regimen for this specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with a histological diagnosis of prostate cancer.
2. Castration sensitive prostate cancer patients.
3. Oligometastatic disease defined as less than or equal 3 lesions based on CT and Bone Scan and less than or equal 5 lesions based on Choline or PSMA PET/TC. Bone metastases (including the spine) or/and lymph nodes metastases.
4. Informed consent is obtained from the patient.
5. Adequate bone-marrow, liver and renal function:

   * Haemoglobin ≥10 g/dL, Leucocytes ≥ 2000/mm\^3, Neutrophils ≥1500/mm\^3, platelets ≥1000007mm\^3
   * GOT, GPT and Total Bilirrubin ≤1.5\*ULN (Upper limit of normality)
   * Creatinine ≤1.5\*ULN or Creatinine Clearance ≥50 ml/min\^-1

Exclusion Criteria:

1. Lack of a histological diagnosis of prostate cancer.
2. Castration resistant prostate cancer patients according to PCWG3\[30\].
3. Metastatic disease defined as greater than or equal 3 lesions based on CT and Bone Scan and greater than or equal 5 lesions based on Choline or PSMA PET/TC.
4. Visceral metastases.
5. Tumor stage T4 according to AJCC 8th Edition Cancer staging form.
6. Prior treatment with docetaxel, second generation hormonal treatments (Apalutamide/Abiraterone+Prednisone/Enzalutamide) or bone antiresorptive therapy.
7. Presence of symptoms or signs that are indicative of urgent surgery/radiotherapy as the first treatment for the metastases disease.
8. Lesions that require SBRT treatment that exceed critical organ tolerance limits, or do not meet the criteria for the prescription of SBRT techniques used.
9. History of another neoplastic pathology which is not a currently controlled with the exception basal cell carcinomas.
10. Presence of a cardiopathy or metabolic disorder that does not recommend the treatment with second generation hormonal treatments, or the presence of inflammatory bowel disease or other pathology that does not recommend the treatment with radiotherapy.
11. Lack of informed consent or the patient's ability to give consent.
12. Participation in other clinical trials at the time of inclusion or in the 3 previous months.

Where it's running

• Hospital Universitario Ramón y Cajal
  Madrid, Spain Recruiting
• Hospital Universitari i Politècnic La Fe
  Valencia, Spain Not yet recruiting

Study contacts

• Principal investigator: Antonio J Conde Moreno, MD PhD — Grupo de Investigación Clínica en Oncología Radioterápica
• Study coordinator: Antonio J Conde Moreno, MD PhD
• Email: antoniojconde@gmail.com
• Phone: +34 649039866

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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.