Combining radiation therapy with hormone treatment for prostate cancer

Phase III Study of Stereotactic Body Radiation Therapy (SBRT) Plus Standard of Care in Castration Sensitive Oligometastatic Prostate Cancer Patients.

This study is testing if adding a special type of radiation therapy to standard treatment can help men with a specific kind of prostate cancer live better and longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sex: Male
• Sponsor: Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic (Academic / other)
• Drugs / interventions: Prednisone, radiation
• Locations: 2 sites (Madrid and 1 other locations)
• Trial ID: NCT05209243 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with a histological diagnosis of castration-sensitive prostate cancer and oligometastatic disease with three or fewer lesions.

Not a fit: Patients with castration-resistant prostate cancer or those with more than three metastatic lesions will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with oligometastatic prostate cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

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 this trial is running

Madrid and 1 other locations

• 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

Conditions Prostate Cancer; Stereotactic Body Radiation Therapy; SBRT; Prostate cancer; Metastatic hormonosensitive prostate cancer; Second generation hormonal treatments; Oligometastatic prostate cancer; Apalutamide