Assessment Schedules for Each Arm
Arm A – SBRT
CTCAE, Common Toxicity Criteria for Adverse Events; EORTC QLQ-30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; EPIC-26, Expanded Prostate Cancer Index Composite 26-item questionnaire; PET-CT, positron emission tomography-computed tomography; RT, radiotherapy
1 ADT, Androgen Deprivation Therapy, all participants will receive a standard of care 12 months of ADT from either the start of radiotherapy or up to one month before starting radiotherapy. Radiotherapy treatment should commence within one month of randomisation. SBRT dose will be 30, 35 or 40 Gy delivered on alternate days over 2 weeks.
2 Follow-up will be carried out either in person or by telephone
3 +/- 1 months, prior +/- 1 week
4 Blood samples will be collected at site before being sent to Dr Alex Clipson at Manchester, please see the sample collection manual and section 12.5 for further information
*PET-CT scans should be completed within 6 months prior to randomisation. ** Re-staging investigations should be prompted by biochemical failure (defined as ≥2 ng/ml increase in PSA above the nadir value achieved after completion of RT) and/ or symptoms suggestive of recurrence. Re-staging with PET-CT is mandated.
Arm B – ENI-5
CTCAE, Common Toxicity Criteria for Adverse Events; EORTC QLQ-30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; EPIC-26, Expanded Prostate Cancer Index Composite 26-item questionnaire; PET-CT, positron emission tomography-computed tomography; RT, radiotherapy
1 ADT, Androgen Deprivation Therapy, all participants will receive a standard of care 12 months of ADT from either the start of radiotherapy or up to one month before starting radiotherapy. Radiotherapy treatment should commence within one month of randomisation. ENI-5 dose will be 25 Gy in 5 fractions plus a SIB of 30, 35 or 40 Gy delivered on alternate days over 2 weeks.
2 Follow-up will be carried out either in person or by telephone
3 +/- 1 months, prior +/- 1 week
4 Blood samples will be collected at site before being sent to Dr Alex Clipson at Manchester, please see the sample collection manual and section 12.5 for further information
*PET-CT scans should be completed within 6 months prior to randomisation. ** Re-staging investigations should be prompted by biochemical failure (defined as ≥2 ng/ml increase in PSA above the nadir value achieved after completion of RT) and/ or symptoms suggestive of recurrence. Re-staging with PET-CT is mandated.
ARM C – ENI-20
CTCAE, Common Toxicity Criteria for Adverse Events; EORTC QLQ-30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; EPIC-26, Expanded Prostate Cancer Index Composite 26-item questionnaire; PET-CT, positron emission tomography-computed tomography; RT, radiotherapy
1 ADT, Androgen Deprivation Therapy, all participants will receive a standard of care 12 months of ADT from either the start of radiotherapy or up to 1 month before starting radiotherapy. Radiotherapy treatment should commence ideally within one month of randomisation. ENI-20 dose will be 44 Gy in 20 fractions plus a simultaneous integrated boost (SIB) of 54 Gy to macroscopically involved node(s) delivered daily over 4 weeks.
2 Follow-up will be carried out either in person or by telephone
3 +/- 1 months, prior +/- 1 week
4 Blood samples will be collected at site before being sent to Dr Alex Clipson at Manchester, please see the sample collection manual and section 12.5 for further information
*PET-CT scans should be completed within 6 months prior to randomisation. ** Re-staging investigations should be prompted by biochemical failure (defined as ≥2 ng/ml increase in PSA above the nadir value achieved after completion of RT) and/ or symptoms suggestive of recurrence. Re-staging with PET-CT is mandated.