Steven E. Canfield, MD; Philipp Dahm, MD, MHSc, FACS
In men with locally advanced prostate cancer, does adding radiation therapy (RT) to androgen deprivation therapy (ADT) reduce mortality?
Interim analysis of a randomized controlled trial (National Cancer Institute of Canada Clinical Trials Group [NCIC CTG] PR.3/Medical Research Council [MRC] UK PR07 trial). ClinicalTrials.gov NCT00002633; Current Controlled Trials ISRCTN 24991896.
≤ 13 years (median 6 y).
> 50 international centers.
1205 men < 80 years of age (median age 70 y) who had histologically confirmed prostate adenocarcinoma with locally advanced disease (clinical tumor stage T3 or T4, N0 or NX, or M0 disease), or clinical T2 tumors with PSA level > 40 ng/mL, or T2 tumor with PSA level > 20 ng/mL and Gleason score > 8; and an Eastern Cooperative Oncology Group performance status of 0 to 2. Exclusion criteria included previous prostate cancer treatment, except neoadjuvant ADT ≤ 12 weeks before randomization. Patients who had surgical staging were excluded if pelvic nodes were not histologically free of disease.
RT plus ADT (n = 603) or ADT alone (n = 602). ADT (bilateral orchiectomy or lifelong luteinizing hormone–releasing hormone agonist) was initiated before randomization. RT (65 to 69 Gray [Gy] in 35 to 37 fractions) was initiated ≤ 8 weeks after randomization, delivered with a 4-field box technique.
All-cause mortality. Secondary outcomes included prostate cancer mortality and adverse events.
91% completed ≥ 2 years of follow-up (intention-to-treat analysis).
The RT plus ADT group had reduced all-cause and prostate cancer mortality at 7 years compared with the ADT alone group (Table). RT-plus-AD and AD-alone groups had similar rates of grade > 3 diarrhea (1% vs < 1%), rectal bleeding (< 1% vs 1%), and genitourinary adverse events (2% vs 2%).
In men with locally advanced prostate cancer, adding radiation therapy to androgen deprivation therapy reduced mortality.
Radiation therapy (RT) plus androgen deprivation therapy (ADT) vs ADT alone in patients with locally advanced prostate cancer†
†Abbreviations defined in Glossary. RRR, NNT, and CI calculated from ADT event rates and hazard ratios in article.
Canfield SE, Dahm P. Radiation plus androgen deprivation therapy reduced mortality in locally advanced prostate cancer. Ann Intern Med. 2012;156:JC4–5. doi: 10.7326/0003-4819-156-8-201204170-02005
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Published: Ann Intern Med. 2012;156(8):JC4-5.
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