Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2023 Jun 10;41(17):3203-3216.
doi: 10.1200/JCO.22.02390. Epub 2023 Apr 27.

Dose-Escalated Radiotherapy Alone or in Combination With Short-Term Androgen Deprivation for Intermediate-Risk Prostate Cancer: Results of a Phase III Multi-Institutional Trial

Daniel J Krauss  1 , Theodore Karrison  2 , Alvaro A Martinez  3 , Gerard Morton  4 , Di Yan  1 , Deborah Watkins Bruner  5 , Benjamin Movsas  6 , Mohamed Elshaikh  6 , Deborah Citrin  7 , Bruce Hershatter  5 , Jeff M Michalski  8 , Jason Alexander Efstathiou  9 , Adam Currey  10 , Vivek S Kavadi  11 , Fabio L Cury  12 , Michael Lock  13 , Adam Raben  14   15 , Samantha Andrews Seaward  16 , Ali El-Gayed  17 , Joseph P Rodgers  18 , Howard M Sandler  19
Affiliations
Multicenter Study

Dose-Escalated Radiotherapy Alone or in Combination With Short-Term Androgen Deprivation for Intermediate-Risk Prostate Cancer: Results of a Phase III Multi-Institutional Trial

Daniel J Krauss et al. J Clin Oncol. .

Abstract

Purpose: It remains unknown whether or not short-term androgen deprivation (STAD) improves survival among men with intermediate-risk prostate cancer (IRPC) treated with dose-escalated radiotherapy (RT).

Methods: The NRG Oncology/Radiation Therapy Oncology Group 0815 study randomly assigned 1,492 patients with stage T2b-T2c, Gleason score 7, or prostate-specific antigen (PSA) value >10 and ≤20 ng/mL to dose-escalated RT alone (arm 1) or with STAD (arm 2). STAD was 6 months of luteinizing hormone-releasing hormone agonist/antagonist therapy plus antiandrogen. RT modalities were external-beam RT alone to 79.2 Gy or external beam (45 Gy) with brachytherapy boost. The primary end point was overall survival (OS). Secondary end points included prostate cancer-specific mortality (PCSM), non-PCSM, distant metastases (DMs), PSA failure, and rates of salvage therapy.

Results: Median follow-up was 6.3 years. Two hundred nineteen deaths occurred, 119 in arm 1 and 100 in arm 2. Five-year OS estimates were 90% versus 91%, respectively (hazard ratio [HR], 0.85; 95% CI, 0.65 to 1.11]; P = .22). STAD resulted in reduced PSA failure (HR, 0.52; P <.001), DM (HR, 0.25; P <.001), PCSM (HR, 0.10; P = .007), and salvage therapy use (HR, 0.62; P = .025). Other-cause deaths were not significantly different (P = .56). Acute grade ≥3 adverse events (AEs) occurred in 2% of patients in arm 1 and in 12% for arm 2 (P <.001). Cumulative incidence of late grade ≥3 AEs was 14% in arm 1 and 15% in arm 2 (P = .29).

Conclusion: STAD did not improve OS rates for men with IRPC treated with dose-escalated RT. Improvements in metastases rates, prostate cancer deaths, and PSA failures should be weighed against the risk of adverse events and the impact of STAD on quality of life.

Trial registration: ClinicalTrials.gov NCT00936390.

PubMed Disclaimer

Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Howard M. Sandler

Consulting or Advisory Role: Janssen

Other Relationship: Caribou Publishing

No other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
CONSORT diagram. STAD, short-term androgen deprivation.
FIG 2.
FIG 2.
Disease control outcomes: (A) OS, (B) prostate cancer–specific mortality, (C) distant metastasis, (D) PSA progression, (E) rates of salvage ADT, and (F) non–prostate cancer–specific mortality. ADT, androgen-deprivation therapy; HR, hazard ratio; OS, overall survival; PSA, prostate-specific antigen; RT, radiotherapy; STAD, short-term androgen deprivation.
FIG 3.
FIG 3.
Patient subset analyses for (A) PSA failure and (B) distant metastasis. HR, hazard ratio; PSA, prostate-specific antigen; RT, radiotherapy; STAD, short-term androgen deprivation. aP value obtained from Cox regression analysis unless otherwise indicated. bP value from logrank test. cConfidence interval omitted because of too few events. dGleason 2-6 upper confidence limit for HR is 26.4.
See this image and copyright information in PMC

Comment in

References

    1. Gandaglia G, Leni R, Bray F, et al. : Epidemiology and prevention of prostate cancer. Eur Urol Oncol 4:877-892, 2021 - PubMed
    1. Burt LM, Shrieve DC, Tward JD: Factors influencing prostate cancer patterns of care: An analysis of treatment variation using the SEER database. Adv Radiat Oncol 3:170-180, 2018 - PMC - PubMed
    1. Jones CU, Hunt D, McGowan DG, et al. : Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med 365:107-118, 2011 - PubMed
    1. Pisansky TM, Hunt D, Gomella LG, et al. : Duration of androgen suppression before radiotherapy for localized prostate cancer: Radiation Therapy Oncology Group randomized clinical trial 9910. J Clin Oncol 33:332-339, 2015 - PMC - PubMed
    1. Pilepich MV, Winter K, John MJ, et al. : Phase III Radiation Therapy Oncology Group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys 50:1243-1252, 2001 - PubMed

Publication types

Associated data