Results of a multicenter, randomized, phase 3 trial of trimodality therapy with I-125 brachytherapy, external beam radiation therapy, and long- versus short-term androgen deprivation therapy for localized high-risk prostate cancer (TRIP/TRIGU0907).

Authors

null

Atsunori Yorozu

National Hospital Organization Tokyo Medical Center, Tokyo, Japan

Atsunori Yorozu , Mikio Namiki , Shiro Saito , Shin Egawa , Hiroshi Yaegashi , Konaka Hiroyuki , Tetsuo Momma , Takashi Fukagai , Nobumichi Tanaka , Toshio Ohashi , Hiroyuki Takahashi , Atsushi Mizokami , Yoko Nakagawa , Takashi Kikuchi , Nelson Stone

Organizations

National Hospital Organization Tokyo Medical Center, Tokyo, Japan, Hasegawa Hospital, Toyama, Japan, Ofuna Chuo Hospital, Kanagawa, Japan, Department of Urology, Jikei University School of Medicine, Tokyo, Japan, Kanazawa University, Kanazawa-Shi, Japan, Japanese Red Cross Society Kanazawa Hospital, Kanazawa, Japan, Showa University School of Medicine, Tokyo, Japan, Nara Medical University School of Medicine, Nara, Japan, Keio University School of Medicine, Tokyo, Japan, Jikei University School of Medicine, Tokyo, Japan, Translational Research Center for Medical Innovation, Kobe, Japan, Mount Sinai Medical Center, New York, NY

Research Funding

Pharmaceutical/Biotech Company
AstraZeneca, Nihon-Mediphysics

Background: The TRIP trial was a multicenter, phase 3 randomized investigation designed to determine whether 30 months of androgen deprivation therapy (ADT) was superior to 6 months of ADT when combined with brachytherapy and external beam radiotherapy (EBRT) for localized high-risk prostate cancer. Methods: The trial was done in 37 hospitals in Japan. Men between 40 to 79 years old with stage T2c-3a, or a prostate-specific antigen (PSA) >20 ng/ml or a Gleason score >7 received 6 months of ADT combined with I-125 brachytherapy at a prescription dose of 110 Gy, followed by EBRT of 45 Gy. Patients were randomly assigned either no further treatment (short arm) or 24 months of adjuvant ADT (long arm) after stratification. The primary endpoint was biochemical progression-free survival using the Phoenix definition of failure. Secondary endpoints included clinical progression, metastasis, salvage treatment, disease-specific survival, overall survival, and grade 3 or higher of adverse events. An intention-to-treat analysis was conducted with survival estimates determined using competing risk analyses. Results: Of 332 patients, 165 were randomized to the short and 167 to the long arm. The median follow-up periods were 9.43 and 9.24 years, respectively. 24 patients have died in each arm. The cumulative incidence for biochemical progression in the short vs. long arm were 10.4% (95% confidence interval [CI] 6.62-16.42) vs 9.5% (5.85-15.46) at 9 years, respectively (p=0.647). The cumulative incidences for clinical progression, distant metastases, salvage treatment, and disease-specific mortality events were not significantly different between the two arms. The overall survival rates of the short arm vs long arm were 87.2% (82.13-92.63%) and 85.9% (80.41-91.77%) at 9 years, respectively (p=0.914). Endocrine-related grade 3 morbidity for short arm vs long arm was 0.6% vs 1.8% (p=0.623), and radiation-related grade 3 morbidity was 1.2% vs 0.6% (p=0.622). Conclusions: In localized high-risk prostate cancer, TRIP did not demonstrate the superiority of 30 months vs. 6 months of ADT when combined with brachytherapy and EBRT. These data suggest that ultra-high radiation doses can be combined with a shorter course of ADT without compromising survival. Clinical trial information: UMIN000003992.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2023 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Prostate Cancer

Track

Prostate Cancer - Advanced,Prostate Cancer - Localized

Sub Track

Therapeutics

Clinical Trial Registration Number

UMIN000003992

Citation

J Clin Oncol 41, 2023 (suppl 6; abstr 305)

DOI

10.1200/JCO.2023.41.6_suppl.305

Abstract #

305

Poster Bd #

A3

Abstract Disclosures