We use cookies necessary to giving you a better online experience. By using our website you consent to all cookies in accordance with our Privacy Policy.
Yes, I accept
Menu
Search Opener
Vienna, Austria

ESTRO 2023

Session Item

Monday
May 15
16:30 - 17:30
Hall A
Prostate SBRT
Federica Ferrario, Italy;
Gilles Crehange, France
Proffered Papers
Clinical
17:00 - 17:10
Prostate RT In high risk or N+ Moderate vs Extreme hypofractionation (PRIME): An Interim analysis
Vedang Murthy, India
OC-0924

Abstract

Prostate RT In high risk or N+ Moderate vs Extreme hypofractionation (PRIME): An Interim analysis
Authors:

Vedang Murthy1, Priyamvada Maitre1, Moses Arunsingh2, Reena Phurailatpam3, Ritesh Mhatre3, Balakrishnan Arun4, Gitanjali Panigrahi1, Pallavi Singh1, Santosh Menon5, Gagan Prakash6, Mahendra Pal6, Amandeep Arora6, Aparna Katdare7, Archi Agrawal8, Venkatesh Rangarajan8, Sadhana Kannan9, Indranil Mallick2

1Tata Memorial Centre, Homi Bhabha National Institute, Radiation Oncology, Mumbai, India; 2Tata Medical Center, Radiation Oncology, Kolkata, India; 3Tata Memorial Centre, Homi Bhabha National Institute, Medical Physics, Mumbai, India; 4Tata Medical Center, Medical Physics, Kolkata, India; 5Tata Memorial Centre, Homi Bhabha National Institute, Pathology, Mumbai, India; 6Tata Memorial Centre, Homi Bhabha National Institute, Surgery, Mumbai, India; 7Tata Memorial Centre, Homi Bhabha National Institute, Radiodiagnosis, Mumbai, India; 8Tata Memorial Centre, Homi Bhabha National Institute, Nuclear Medicine and Molecular Imaging, Mumbai, India; 9Tata Memorial Centre, Homi Bhabha National Institute, Clinical Research Secretariat, Mumbai, India

Show Affiliations
Purpose or Objective

Safety of SBRT for high-risk and node-positive prostate cancer is not yet established. We report 90-day toxicity and QOL from the pre-planned interim analysis of the ongoing phase III, multicentric, randomised PRIME trial (NCT03561961).

Material and Methods

Patients with NCCN high-risk or node-positive prostate adenocarcinoma (non-regional nodes or distant metastases excluded) are being randomised 1:1 to moderate (MHRT) or extreme (SBRT) hypofractionated RT. Patients in the MHRT arm received 68Gy/25# or 62Gy/20# to prostate, 50Gy/25# or 44Gy/20# to the pelvis, and in the SBRT arm 36.25Gy/5# with 25Gy/5# to the pelvis. ADT was prescribed for at least 24 months without systemic intensification. Toxicity using CTCAE v5.0, and QOL using EORTC QLQC-30 and PR-25 was recorded at baseline, RT completion, at 3-6 weeks, and then 3-6 monthly, with a threshold of 10 points change in the mean QOL scores for minimal clinically important change (MCIC). While the trial targets a sample of 464 for primary endpoint of 5-year biochemical failure-free survival, we report the cumulative 90-day toxicity and QOL for patients randomised till a pre-planned interim analysis.

Results

Total 307 randomised patients (N0=241, N1=66) were analysed, MHRT=153 and SBRT=154. Of these, 296 received RT and were eligible for toxicity reporting. Table 1 shows the cumulative 90-day urinary (GU) and gastrointestinal (GI) toxicities. Grade 3 GU toxicity was low, and observed in 3 patients (SBRT=1, MHRT=2), GI in 2 patients (1 each in MHRT and SBRT), without any grade 4 toxicity. Grade 2 acute GU and GI toxicities were similar for MHRT and SBRT (GU 33.1% vs 31.8%, p=0.5; GI 17.2 vs 15.2, p=0.9). Change in the mean QOL scores before and after RT for urinary symptoms was 9.4 for MHRT (26.6 to 36.0) and 5.1 for SBRT (27.5 to 32.6). For GI symptoms, the change in mean QOL was 1.9 for MHRT (7.4 to 9.3) and 0 for SBRT (6.7 to 6.7). Both of these were below the pre-defined threshold of MCIC.

Table 1: Cumulative 90-day urinary and gastrointestinal toxicities [*CTCAE grade 3 toxicity in parentheses, others grade 2]


Conclusion

Interim analysis from the ongoing multicentric randomised trial PRIME showed low rate of grade 3 acute toxicities for MHRT and SBRT, with similar toxicities and QOL for these two hypofractionated schedules of radiotherapy in high risk and node positive prostate cancer.