Table 3.
Randomized prospective trials assessing stereotactic body radiation therapy (SBRT) as a treatment for localized prostate cancer.
| Trial Identifier | Coutnry | Risk Groups | Arms (Standard/Experimental) | Primary Outcome | Measure |
|---|---|---|---|---|---|
|
NCT03830788
TEMPOS |
France | LR and IR | LDR-BT SBRT |
Medico-economic | Cost-utility analysis |
|
NCT02895854
BRAVEROBO |
Finland | LR and IR | LDR-BT SBRT |
Toxicity | CTCAE |
| NCT04870567 | Russia | LR and IR | HDR-BT SBRT |
Toxicity and erectile dysfunction | CTCAE and PROs |
|
NCT03525262
POTEN-C |
USA | LR and IR | SBRT SBRT (neurovascular sparing) |
Sexual toxicity | PROs (Sexual function) |
|
NCT05019846
SPA |
Italy | IR and HR | SBRT SBRT + 6m ADT |
Efficacy | bRFS |
| NCT03056638 | USA | IR | SBRT SBRT + 6m ADT: |
Efficacy | 2y biopsies |
|
NCT03253978
SPORT |
UK | HR | SBRT + ADT SBRT with pelvis (SIB) + ADT |
Toxicity | CTCAE and PROs |
|
ISRCTN45905321
HYPO-RT-PC |
Sweden | IR and HR | EBRT SBRT |
Efficacy | bRFS |
|
NCT01584258
PACE A B C |
UK | LR and IR LR and IR IR and HR |
PACE-A Prostatectomy SBRT PACE-B EBRT SBRT PACE-C EBRT + ADT SBRT + ADT |
Efficacy Efficacy Efficacy |
bRFS bRFS bRFS |
|
NCT01794403
HEAT |
USA | LR and IR | EBRT SBRT |
Efficacy | bRFS and 2y biopsies |
|
NCT03367702
NRG-GU005 |
USA | IR | EBRT SBRT |
Toxicity | PROs |
|
NCT02361515
RPAH2 |
France | LR and IR | EBRT SBRT (rectal spacer) |
Toxicity | CTCAE |
|
NCT02594072
ASSERT |
Canada | IR and HR | EBRT + ADT SBRT + ADT |
Toxicity | CTCAE |
|
NCT03380806
PBS |
Canada | HR | EBRT + ADT EBRT + SBRT boost + ADT |
Toxicity | PROs |
| NCT01839994 | Poland | IR and HR | EBRT + ADT EBRT + HDR-BT boost + ADT or EBRT + SBRT boost + ADT |
Efficacy | bRFS |
|
NCT02300389
HYPOPROST |
Poland | HR | EBRT + ADT EBRT + SBRT boost + ADT |
Efficacy | bRFS |
| NCT04100174 | Canada | IR and HR | EBRT + HDR-BT boost SBRT + focal HDR-BT boost |
Urinary toxicity | PROs (Urinary function) |
LR = low-risk; IR = intermediate-risk; HR = high-risk; LDR = low-dose rate; HDR = high-dose rate; BT = brachytherapy; SBRT = stereotactic body radiation therapy; EBRT = external beam radiation therapy; ADT = androgen deprivation therapy; SIB = simultaneous integrated boost; bRFS = biological recurrence free survival; CTCAE = Common Terminology Criteria for Adverse Events; PROs = patient reported outcomes.