PMID- 37104748
OWN - NLM
STAT- MEDLINE
DCOM- 20230609
LR  - 20240110
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 41
IP  - 17
DP  - 2023 Jun 10
TI  - 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.
PG  - 3203-3216
LID - 10.1200/JCO.22.02390 [doi]
AB  - 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.
FAU - Krauss, Daniel J
AU  - Krauss DJ
AUID- ORCID: 0000-0003-3703-2738
AD  - Corewell Health Beaumont University Hospital, Royal Oak, MI.
FAU - Karrison, Theodore
AU  - Karrison T
AD  - NRG Oncology Statistics and Data Management Center, University of Chicago, 
      Chicago, IL.
FAU - Martinez, Alvaro A
AU  - Martinez AA
AD  - 21st Century Oncology of Michigan, Pontiac, MI.
FAU - Morton, Gerard
AU  - Morton G
AUID- ORCID: 0000-0002-4903-1233
AD  - Toronto-Sunnybrook Regional Cancer Center, Toronto, ON, Canada.
FAU - Yan, Di
AU  - Yan D
AUID- ORCID: 0000-0003-1977-8448
AD  - Corewell Health Beaumont University Hospital, Royal Oak, MI.
FAU - Bruner, Deborah Watkins
AU  - Bruner DW
AUID- ORCID: 0000-0002-5770-9948
AD  - Emory University, Atlanta, GA.
FAU - Movsas, Benjamin
AU  - Movsas B
AUID- ORCID: 0000-0003-2703-9776
AD  - Henry Ford Cancer Institute, Detroit, MI.
FAU - Elshaikh, Mohamed
AU  - Elshaikh M
AD  - Henry Ford Cancer Institute, Detroit, MI.
FAU - Citrin, Deborah
AU  - Citrin D
AUID- ORCID: 0000-0002-4391-2734
AD  - National Cancer Institute, Bethesda, MD.
FAU - Hershatter, Bruce
AU  - Hershatter B
AD  - Emory University, Atlanta, GA.
FAU - Michalski, Jeff M
AU  - Michalski JM
AUID- ORCID: 0000-0003-0563-3766
AD  - Washington University School of Medicine, Saint Louis, MO.
FAU - Efstathiou, Jason Alexander
AU  - Efstathiou JA
AUID- ORCID: 0000-0003-0996-0350
AD  - Dana-Farber/Harvard Cancer Center, Boston, MA.
FAU - Currey, Adam
AU  - Currey A
AUID- ORCID: 0000-0002-4099-712X
AD  - Froedtert and the Medical College of Wisconsin, Milwaukee, WI.
FAU - Kavadi, Vivek S
AU  - Kavadi VS
AUID- ORCID: 0000-0002-0460-1730
AD  - The US Oncology Network, Fairfax, VA.
FAU - Cury, Fabio L
AU  - Cury FL
AUID- ORCID: 0000-0003-1293-0822
AD  - McGill University Health Center, Montreal, QC, Canada.
FAU - Lock, Michael
AU  - Lock M
AUID- ORCID: 0000-0002-3782-4463
AD  - London Regional Cancer Program, London, ON, Canada.
FAU - Raben, Adam
AU  - Raben A
AD  - Delaware/Christiana Care NCI Community Oncology Research Program, Newark, DE.
AD  - Milwaukee Veterans Administration Medical Center, Milwaukee, WI.
FAU - Seaward, Samantha Andrews
AU  - Seaward SA
AUID- ORCID: 0000-0003-4459-4923
AD  - Kaiser Permanente NCI Community Oncology Research Program, Oakland, CA.
FAU - El-Gayed, Ali
AU  - El-Gayed A
AUID- ORCID: 0000-0002-4581-2892
AD  - Saskatoon Cancer Centre, Saskatoon, SK, Canada.
FAU - Rodgers, Joseph P
AU  - Rodgers JP
AD  - NRG Oncology Statistics and Data Management Center, Philadelphia, PA.
FAU - Sandler, Howard M
AU  - Sandler HM
AUID- ORCID: 0000-0002-8193-5769
AD  - Cedars-Sinai Medical Center, Los Angeles, CA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00936390
GR  - U10 CA180868/CA/NCI NIH HHS/United States
GR  - UG1 CA189867/CA/NCI NIH HHS/United States
GR  - UG1 CA189821/CA/NCI NIH HHS/United States
GR  - U24 CA180803/CA/NCI NIH HHS/United States
GR  - U10 CA180822/CA/NCI NIH HHS/United States
GR  - UG1 CA233339/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
DEP - 20230427
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
RN  - 0 (Androgens)
RN  - 0 (Androgen Antagonists)
SB  - IM
CIN - Eur Urol. 2023 Dec;84(6):600-601. PMID: 37438199
MH  - Male
MH  - Humans
MH  - *Prostatic Neoplasms/drug therapy/radiotherapy
MH  - Prostate-Specific Antigen
MH  - Androgens/therapeutic use
MH  - Androgen Antagonists/adverse effects
MH  - Quality of Life
MH  - Disease-Free Survival
MH  - Combined Modality Therapy
MH  - Radiotherapy Dosage
PMC - PMC10489479
COIS- 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.
EDAT- 2023/04/27 18:41
MHDA- 2023/06/09 06:42
PMCR- 2024/06/10
CRDT- 2023/04/27 16:13
PHST- 2024/06/10 00:00 [pmc-release]
PHST- 2023/06/09 06:42 [medline]
PHST- 2023/04/27 18:41 [pubmed]
PHST- 2023/04/27 16:13 [entrez]
AID - JCO.22.02390 [pii]
AID - 10.1200/JCO.22.02390 [doi]
PST - ppublish
SO  - J Clin Oncol. 2023 Jun 10;41(17):3203-3216. doi: 10.1200/JCO.22.02390. Epub 2023 
      Apr 27.