Tests extra body radiation with standard care for prostate cancer spread to few sites
Tests extra body radiation with standard care in men with prostate cancer spread.
Plain-language title generated from the registry record
Registry title: START-MET HS Prostate Cancer. : SbrT & Androgen Receptor Therapy METastatic HSPC
Key facts
- Where
- Madrid and Valencia, SpainSee the 2 sites
Where in Spain
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Universitari i Politécnic La FeValencia, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
- Trial code
- NCT05209243
- Record updated
- 19 May 2023
- Original description
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 radiotherapy to the primary tumor in previously not treated patients and second generation hormonal treatments (Apalutamide/Abiraterone+Prednisone/Enzalutamide) vs androgen deprivation therapy plus radiotherapy to the primary tumor in previously not treated patients plus second generation hormonal treatments, for the treatment of oligometastatic prostate cancer.Read full original descriptionShow less
Phase III Study of Stereotactic Body Radiation Therapy (SBRT) Plus Standard of Care in Castration Sensitive Oligometastatic Prostate Cancer Patients.
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 radiotherapy to the primary tumor in previously not treated patients and second generation hormonal treatments (Apalutamide/Abiraterone+Prednisone/Enzalutamide) vs androgen deprivation therapy plus radiotherapy to the primary tumor in previously not treated patients plus second generation hormonal treatments, for the treatment of oligometastatic prostate cancer.
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: Prior treatment with docetaxel, second generation hormonal treatments (Apalutamide/Abiraterone+Prednisone/Enzalutamide) or bone antiresorptive therapy; 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; Participation in other clinical trials at the time of inclusion or in the 3 previous months; 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; Tumor stage T4 according to AJCC 8th Edition Cancer staging form; Presence of symptoms or signs that are indicative of urgent surgery/radiotherapy as the first treatment for the metastases disease; History of another neoplastic pathology which is not a currently controlled with the exception basal cell carcinomas; Visceral metastases; Lesions that require SBRT treatment that exceed critical organ tolerance limits, or do not meet the criteria for the prescription of SBRT techniques used; Lack of informed consent or the patient's ability to give consent.