Safety and Efficacy of Virtual Prostatectomy With Single-Dose Radiotherapy in Patients With Intermediate-Risk...

Area of Science:

• Radiation Oncology
• Urologic Oncology
• Clinical Trials

Background:

• Ultra-high single-dose radiotherapy (SDRT) is explored as an alternative to extreme hypofractionated stereotactic body radiotherapy (SBRT) for organ-confined prostate cancer.
• The PROSINT trial (NCT02570919) is a phase 2 randomized clinical trial comparing SDRT and SBRT.

Purpose of the Study:

• To compare the toxic effect profiles of SDRT versus extreme hypofractionated SBRT.
• To evaluate prostate-specific antigen (PSA) responses and quality-of-life outcomes between SDRT and SBRT.

Main Methods:

• 30 patients with intermediate-risk prostate cancer were randomized 1:1 to receive either 5x9 Gy SBRT or 24 Gy SDRT.
• Androgen deprivation therapy was not permitted.
• Toxic effects, PSA response, PSA relapse-free survival, and quality of life (IPSS, EPIC-26) were assessed.

Main Results:

• Acute and late toxic effects were similar between SDRT and SBRT arms, with no significant differences in grade 1 or grade 2+ urinary toxicity.
• Late gastrointestinal toxicity was comparable, with no grade 2+ events observed in either arm.
• PSA levels declined similarly in both arms; 4-year PSA relapse-free survival was 75.0% for SBRT vs. 64.0% for SDRT in unfavorable intermediate-risk disease. Quality of life scores showed transient declines but returned to baseline by 3 months.

Conclusions:

• SDRT is a safe and effective treatment option for intermediate-risk prostate cancer, demonstrating low toxicity.
• Tumor control and quality-of-life outcomes for SDRT closely match those of SBRT.
• Further research is warranted to establish definitive indications for SDRT in prostate cancer treatment.