Status:
RECRUITING
START-MET HS Prostate Cancer. : SbrT & Androgen Receptor Therapy METastatic HSPC
Lead Sponsor:
Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
Conditions:
Prostate Cancer
Stereotactic Body Radiation Therapy
Eligibility:
MALE
Phase:
NA
Brief Summary
Phase III study of stereotactic body radiation therapy (SBRT) plus standard of care in castration sensitive oligometastatic prostate cancer patients, defined as androgen deprivation therapy plus radio...
Detailed Description
A total of 266 patients with a histological diagnosis of metastatic hormone sensitive prostate cancer, with limited disease (≤ 3 lesions based on CT and Bone Scan and ≤ 5 lesions based on Choline or P...
Eligibility Criteria
Inclusion
- Patients with a histological diagnosis of prostate cancer.
- Castration sensitive prostate cancer patients.
- 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.
- Informed consent is obtained from the patient.
- 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
- Lack of a histological diagnosis of prostate cancer.
- Castration resistant prostate cancer patients according to PCWG3\[30\].
- 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.
- Visceral metastases.
- Tumor stage T4 according to AJCC 8th Edition Cancer staging form.
- Prior treatment with docetaxel, second generation hormonal treatments (Apalutamide/Abiraterone+Prednisone/Enzalutamide) or bone antiresorptive therapy.
- Presence of symptoms or signs that are indicative of urgent surgery/radiotherapy as the first treatment for the metastases disease.
- Lesions that require SBRT treatment that exceed critical organ tolerance limits, or do not meet the criteria for the prescription of SBRT techniques used.
- History of another neoplastic pathology which is not a currently controlled with the exception basal cell carcinomas.
- 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.
- Lack of informed consent or the patient's ability to give consent.
- Participation in other clinical trials at the time of inclusion or in the 3 previous months.
Key Trial Info
Start Date :
January 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT05209243
Start Date
January 26 2023
End Date
January 1 2027
Last Update
May 19 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
2
Hospital Universitari i Politècnic La Fe
Valencia, Spain