Table 4.
Ongoing trials with SBRT in prostate cancer.
| Identification Number NCT | Type of Study/Phase | n | Arm and Intervention | Primary Objective |
|---|---|---|---|---|
| NCT01766492 | Phase III | 622 | Experimental arm, SBRT 36.25 Gy in five fractions. Control arm, IMRT 70 Gy in 28 fractions. |
Determine whether SBRT is superior to IMRT in terms of genitourinary (GU) and gastrointestinal (GI) toxicity and quality of life. |
| NCT01584258 | Phase III | 1716 | Laparoscopic prostatectomy versus SBRT for patients for whom surgery is considered. (PACE-A trial). Patients not candidates for surgery, normofractionated RT (78 Gy in 39 fractions) versus SBRT 36.25 Gy in 5 fractions (PACE-C trial) |
Biochemical relapse-free survival. |
| NCT03830788 | Phase III | 240 | SBRT 36.25 Gy/7.25. Gy/versus low dose rate brachytherapy | Cost-effectiveness analysis of SBRT compared to low dose rate brachytherapy, 3 years after the end of treatment. |
| NCT01985828 | Phase II | 72 | Evaluates the efficacy of SBRT with CyberKnife in treating RI prostate ADC (alone and as BOOST) and AR. Experimental arm, intermediate-risk ADD (4–6 months) + CyberKnife 36.35 Gy in 5 fractions (monotherapy) ADD (4–6 months) + IMRT prostate/seminal vesicles (45–50.4 Gy) + BOOST with SBRT (21 Gy in 3 fractions). Experimental, high-risk ADD (6 months–3 years) + IMRT 45–50.4 Gy on pelvis and prostate + SBRT BOOST 21 Gy (7 Gy × 3) |
Survival free of biochemical recurrence at 5 years. |
| NCT03294889 | Phase II | 45 | SBRT single session 19 Gy in localized prostate cancer. | Acute GI and GU toxicity three months after the end of treatment. CTCAE v.4.03. Survival free of biochemical relapse at 3 years. |
| NCT01618851 | Phase II | 70 | Evaluate the effectiveness of SBRT BOOST with Cyberknife after IMRT. IMRT 45 Gy in 25 fractions + BOOST with SBRT with Cyberknife 19.5 Gy in 3 |
Estimate the local relapse rate assessed by 2-year postradiotherapy prostate biopsy. |
| NCT03380806 | Phase II | 100 | Compare BOOST with conventional radiotherapy vs. SBRT after pelvic radiotherapy (45 Gy in 25 fractions). In both arms, ADD is maintained for 3 years. Arm 1: Conventional pelvic radiotherapy + BOOST with conventional radiotherapy (33–35 Gy in 16 fractions). Arm 2: Conventional pelvic radiotherapy + BOOST with SBRT 19.5–21 Gy in 3 fractions. |
Evaluate the quality of life at 6 months of treatment. Evaluate quality of life, late GI and GU, and IPSS toxicity at 12–24 months. |
| NCT02313298 | Phase II | 80 | SBRT in localized prostate cancer. 36.25 Gy in 5 fractions. | Severe late GI and GU toxicity rate. |
| NCT03541850 | Phase II | 60 | SBRT 34 Gy in 5 fractions, on alternate days, on prostate bed. | Survival free of biochemical recurrence at 5 years. Acute and late toxicity at 5 years. |