The Current Role of Androgen Deprivation in Patients Undergoing Dose-Escalated External Beam Radiation Therapy for Clinically Localized Prostate Cancer

Table 2

Current Trials.

Trial	Arms	Population	Objective
Zapatero et al. [21]	76 Gy (HDRT) + 4 mos. (nADT+cADT) or HDRT + 2 yrs. aADT	Planned enrollment 358 (preliminary results reported in 298 pts [21]; Intermediate and high-risk PC	Primary endpoints are biochemical disease-free survival and toxicity scores.
RTOG 08–15 [37]	Dose-escalated RT ± ADT (intermediate risk disease)	Planned enrollment 1520; Intermediate risk PC	Primary end-point is OS with secondary end point of acute and late toxicities.
RTOG 09–24 [33]	ADT + RT (high dose) ± WPRT in unfavorable intermediate or favorable high-risk pts.	Planned enrollment 2580; Intermediate and high risk PC	OS of patients treated with ADT and RT versus ADT and WPRT.
NCT00967863 [34]	80 Gy + ADT vs 70 Gy RT + ADT	Planned enrollment 500; High risk PC	The trial is primarily designed to look at biochemical or clinical progression-free survival at 5 years. OS, CSS, and toxicity are the secondary end points of the study.
NCT00223145 [35]	RT (dose escalation from 70–76 Gy) + nADT and cADT or RT (76 Gy) + nADT and cADT in IR PC pts.	Planned enrollment 600; Intermediate risk PC	This is an efficacy study looking at biochemical failure and DFS. The secondary endpoints are OS and toxicity.
NCT00104741 [36]	80 Gy conformal RT ± nADT and cADT	Planned enrollment 450; Intermediate risk PC	Primary end-point: efficacy, 5-year-survival, OS and toxicity.

HDRT: High dose radiation therapy, mos.: Months, yrs.: Years, ADT: Androgen deprivation therapy, nADT: Neo-adjuvant androgen deprivation therapy, cADT: Concomitant androgen deprivation therapy, aADT: Adjuvant androgen deprivation therapy, OS: Overall survival, RTOG: Radiation therapy oncology group, PBRT: Radiation therapy to prostate bed only, wks.: weeks,STADT: Short term androgen deprivation therapy, LTADT: Long term androgen deprivation therapy PLNRT: Pelvic lymph node radiation therapy, LN: Lymph node, WPRT: Whole pelvic radiation therapy, 3D-CRT: 3-Dimensional conformal radiation therapy, IMRT: Intensity modulated radiation therapy, DFS: Disease free survival.