Trial Outcomes & Findings for Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients. (NCT NCT03644303)

Of the 86 patients registered for screening, 85 patients met eligibility criteria and passed screening. Of the 85 patients that passed screening, 81 patients were eligible to receive trial treatment. The trial aimed to treat 84 patients but only 81 patients received trial treatment - once 85 patients has been registered and passed screening, patient drop out exceeded the number expected, and patients were not replaced.

Race and Ethnicity were not collected from any participant.

Median progression free survival following SBRT to progression, starting new treatment or death from any cause. Progression is defined as one of the following; (i) PSA progression: PSA rise by at least 25% over post-SBRT baseline (set at 4 weeks), confirmed by a second reading at least 4 weeks later, (ii) Radiological progression: at least 2 new lesions on bone scan or unequivocal progression of soft tissue on CT, or evidence on other local imaging of disease progression (e.g. PET or MRI progression) as per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) (iii) Symptomatic progression: new or progressing symptoms at the site of a metastasis, or (iv) Date at which the clinician decides to stop Abiraterone/Enzalutamide or starts new line of therapy, whichever occurs sooner.

Number of patients that had a PFS event following SBRT in the duration of the study. Progression free survival definition is time from SBRT to progression, starting new treatment or death from any cause. Progression is defined as one of the following; (i) PSA progression: PSA rise by at least 25% over post-SBRT baseline (set at 4 weeks), confirmed by a second reading at least 4 weeks later, (ii) Radiological progression: at least 2 new lesions on bone scan or unequivocal progression of soft tissue on CT, or evidence on other local imaging of disease progression (e.g. PET or MRI progression) as per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) (iii) Symptomatic progression: new or progressing symptoms at the site of a metastasis, or (iv) Date at which the clinician decides to stop Abiraterone/Enzalutamide or starts new line of therapy, whichever occurs sooner.

Progression free survival estimates following SBRT to progression, starting new treatment or death from any cause. Progression is defined as one of the following; (i) PSA progression: PSA rise by at least 25% over post-SBRT baseline (set at 4 weeks), confirmed by a second reading at least 4 weeks later, (ii) Radiological progression: at least 2 new lesions on bone scan or unequivocal progression of soft tissue on CT, or evidence on other local imaging of disease progression (e.g. PET or MRI progression) as per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) (iii) Symptomatic progression: new or progressing symptoms at the site of a metastasis, or (iv) Date at which the clinician decides to stop Abiraterone/Enzalutamide or starts new line of therapy, whichever occurs sooner.

Overall control defined as stable disease or partial response of irradiated metastases assessed using the RECIST (v 1.1) criteria on imaging such as computed Tomography (CT), magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scan or control on bone scan

Median OS following SBRT until death from any cause.

Number of patients who had an OS event following SBRT in the duration of the study. Overall survival definition is time from SBRT to death from any cause.

OS estimates following SBRT to death from any cause.

Median time following SBRT to alternative therapy administration or death.

Number of patients that started new treatment or died following SBRT in the duration of the study.

Time estimates from SBRT to alternative therapy administration or death.

Patient Reported Quality of Life assessed using the EuroQol (EQ) EQ-5D-5L questionnaire. VAS scale is from 0-100. A higher VAS score indicates better quality-of-life. Outcome data has been reported for (i) all completed assessments and for (ii) assessments conducted up to the point of disease progression, in order to exclude the potential influence of progression on quality-of-life outcomes.

Severity of acute and late side-effects resulting from SBRT assessed using the RTOG (Radiation Therapy Oncology Group) scoring criteria. A higher RTOG grade suggests higher severity of symptoms. Overall maximum grade for each patient at each timepoint is reported.

Severity of acute and late side-effects resulting from SBRT assessed using the Common Terminology Criteria for Adverse Events (CTCAE). A higher CTCAE grade suggests higher severity of symptoms. Overall maximum grade for each patient at each timepoint is reported.

Prostate Specific Antigen (PSA) values recorded post-SBRT