Patient-reported Quality of Life in PROFIT, a Phase 3 Randomized Clinical Trial Evaluating Moderately...

Area of Science:

• Oncology
• Radiation Oncology
• Clinical Trials

Background:

• The PROFIT trial previously established similar efficacy and toxicity for moderately hypofractionated (HF) versus conventional fractionation (CF) radiotherapy in intermediate-risk prostate cancer (IR-PC).
• Long-term patient-reported outcomes (PROs) are crucial for evaluating treatment effectiveness and patient experience.

Purpose of the Study:

• To compare long-term patient-reported outcomes (PROs) between moderately hypofractionated (HF) radiotherapy and conventional fractionation (CF) in patients with intermediate-risk prostate cancer (IR-PC).

Main Methods:

• A phase 3 randomized clinical trial (PROFIT) involving 1206 IR-PC patients.
• Patients received either 78 Gy in 39 fractions over 8 weeks (CF) or 60 Gy in 20 fractions over 4 weeks (HF).
• PROs were assessed using the Expanded Prostate Cancer Index Composite, AUASS, and SF-12 at baseline, 24, and 48 months.

Main Results:

• No significant differences were observed in urinary, bowel, sexual, or hormonal domains between HF and CF arms.
• The sexual domain showed the greatest decline over time in both groups.
• A significant improvement favoring HF was noted in bowel subdomain scores at 48 months (p=0.001).

Conclusions:

• Patient-reported outcomes and health-related quality of life (HRQoL) are comparable between moderate HF and CF radiotherapy for IR-PC.
• This provides level 1 evidence supporting the use of moderate HF radiotherapy as a standard treatment for IR-PC.
• High overall treatment satisfaction was reported in both arms.