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. 2019 Aug 20;9(8):e030731. doi: 10.1136/bmjopen-2019-030731

Table 3.

Schedule of assessments as per StandardProtocol Items: Recommendations for Interventional Trial guidelines

Assessment Pre-treatment Treatment Follow-up
Pre-registration* Baseline † Post SBRT‡ Every 6 months§ 24, 60 months§
Informed consent
Eligibility assessment
Staging investigations¶
Clinical examination
Adverse event
PSA
PRO EPIC 26+/-IIEF 25

*To be done within 60 days of registration.

†To be done no more than 2 weeks post-registration and within 4 weeks of starting treatment.

‡To be performed between 6 weeks post-SBRT treatment completion.

§From commencement of androgen deprivation therapy.

¶Note that PSMA-PET is mandated for high-risk patients. Whole body bone scan with CT or MRI of the pelvis ± abdomen are acceptable for unfavourable intermediate risk patients.

EPIC, Expanded Prostate Cancer Index Composite; PSA, prostate-specific antigen; SBRT, stereotactic body radiotherapy.