NCT05209243Recruiting
START-MET HS Prostate Cancer. : SbrT & Androgen Receptor Therapy METastatic HSPC
Phase III Study of Stereotactic Body Radiation Therapy (SBRT) Plus Standard of Care in Castration Sensitive Oligometastatic Prostate Cancer Patients.
Source: ClinicalTrials.gov · Last updated 19 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 266 (estimated)
- First submitted
- 10 Jan 2022
- Start date
- 26 Jan 2023
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT05209243
What you commit to
- Study type: Interventional
- Planned participants: 266
- From 26 Jan 2023 to the primary completion date, 31 Jan 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.