Norkus 2009.

Methods	Parallel RCT Setting: tertiary cancer center Lithuania Dates: 2004 to not reported Follow‐up: minimum 12 months Randomization ratio: 1:1 CCT
Participants	91 men Inclusion criteria: men with localized prostate cancer (T1–3A), low‐to‐intermediate risk with risk of seminal vesicle or pelvic lymph node (or both) involvement of < 15% (Partin's nomograms and Roach formula). Exclusion criteria: neoadjuvant AD therapy or surgical castration prior to surgery Diagnostic criteria: not stated
Interventions	Number of study centers: 1 Run‐in period: not stated Extension period: no Experimental arm: 47/47 participants Conventional arm: 44/44 participants Complex interventions: Experimental arm: 57 Gy in 17 fractions over 3.5 weeks +4 fractions of 4.5 Gy Conventional arm: 74 Gy in 37 fractions over 7.5 weeks (see Table 8)
Outcomes	Primary outcome OS Secondary outcomes FFBR Biochemical response to treatment Acute and late GI/GU toxicity Assessed weekly for 12 weeks from start of treatment for acute toxicity, with PSA tested every 3 months during the first year, then every 6 months thereafter. Complete outcome measures reported: yes (FFBR reported at 12 months' follow‐up)/no other outcomes reported
Funding sources	Not stated
Declarations of interest	Not stated
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "The protocol was designed to randomize patients … ", page 470. Material and methods, paragraph 1. Comment: this domain deemed at unclear risk of bias because no details provided.
Allocation concealment (selection bias)	Unclear risk	No details provided with respect to allocation concealment, therefore, this domain deemed at unclear risk of bias.
Blinding of participants and personnel (performance bias) Subjective outcomes	Unclear risk	Not mentioned, probably not done. We deemed this domain at unclear risk of bias PC‐SS: not reported Late EORTC/RTOG GI RT toxicity: not reported Late EORTC/RTOG GU RT toxicity: not reported M‐FS: not reported BR‐FS: not reported in usable form Acute EORTC/RTOG GI RT toxicity: not reported Acute EORTC/RTOG GU RT toxicity: not reported Health‐related quality of life: not reported
Blinding of participants and personnel (performance bias) Objective outcomes	Low risk	Not mentioned, probably not done. We deemed this domain at unclear risk of bias. OS: low risk of bias Second malignancy: not reported
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Quote from publication: "Patients were evaluated weekly for 12 weeks starting from the beginning of irradiation. PSA tests were performed every 3 months during the first year after irradiation and every 6 months later. Descriptive statistics were used to characterize the patient age, disease stage", page 470. Materials and methods, paragraph 4. Comment: although there was no mention of blinding, the prespecified protocol for PSA testing would mean this domain was at low risk of bias. PC‐SS was deemed at low risk of bias (not a compound endpoint) (see Table 2). No details given with respect to blinding of outcome assessors for the subjective outcomes of acute and late toxicity. No details given about the method used to score toxicity. We deemed the following outcomes at unclear risk of bias. PC‐SS: not reported Late EORTC/RTOG GI RT toxicity: not reported Late EORTC/RTOG GU RT toxicity: not reported M‐FS: not reported BR‐FS: not reported in usable form Acute EORTC/RTOG GI RT toxicity: not reported Acute EORTC/RTOG GU RT toxicity: not reported Health‐related quality of life: not reported
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Blinding not mentioned, deemed at low risk of bias OS: low risk of bias Second malignancy: not reported
Incomplete outcome data (attrition bias)	Unclear risk	There was no information provided about attrition, and it was unclear if this was an interim report for an ongoing study, or the included 91 men represented the entire cohort. We deemed this domain at unclear risk of bias. Number of participants reported on by outcome PC‐SS: not reported in usable form Late EORTC/RTOG GI RT toxicity: not reported in usable form Late EORTC/RTOG GU RT toxicity: not reported in usable form OS: reported in 91/91 participants DM‐FS: not reported in usable form BR‐FS: not reported in usable form Acute EORTC/RTOG GI RT toxicity: not reported in usable form Acute EORTC/RTOG GU RT toxicity: not reported in usable form Second malignancy: not reported Quality of life: not reported in usable form
Selective reporting (reporting bias)	Unclear risk	Quote from publication: "preliminary report", page 469. Abstract The outcomes detained in the paper comprise: OS, FFBR, PSA response, acute and late toxicity. Outcomes reported (at 12 months' follow‐up): deaths, biochemical relapse. Comment: as this is a preliminary report, we deemed this domain at unclear risk of bias.
Other bias	Low risk	We found no evidence of other sources of bias.