Table 3. Randomized studies on combination ADT/RT for intermediate-risk prostate cancer.
Study | Inclusion | Radiotherapy dose | ADT duration NAJ + CC + ADJ (months) | Overall survival; cause specific survival | Significant toxicity differences (ADT vs. none) |
---|---|---|---|---|---|
RTOG 94-08† | cT1b-T2b, PSA <20 | EBRT 66.6 Gy to prostate | 2+2+0=4 | 62% vs. 56% @ 10 yrs; 96% vs. 92% @ 10 yrs | GI, GU, endocrine, cardiac, dermatologic, and hematologic measured: Gr. 3 new impotence 27% vs. 23% |
Harvard/DFCI† | cT1b-T2b, PSA ≥10, Gleason ≥7 | EBRT 70 Gy to prostate | 2+2+2=6 | 74% vs. 61% @ 8 yrs; not reported (improved hazard ratio) | GI, GU, endocrine, dermatologic measured: Gr. 1 Gynecomastia (18% vs. 3%); Gr 3 new impotence (27% vs. 20%) |
GETUG 14 | Intermediate-risk | EBRT 80 Gy to prostate | 2+2+0=4 | NS; not reported | GI, GU measured: no differences |
RTOG 0815 | NCCN intermediate-risk except pts with all 3 risk factors & ≥50% positive cores | EBRT 79.2 Gy to prostate OR | 2+2+2=6 | Pending report | Pending report |
†, some patients on these trials were high-risk. All trials use GnRH agonist + antiandrogen for ADT. NAJ, neoadjuvant; CC, concurrent; ADJ, adjuvant; NS, not statistically significant; ADT, androgen deprivation therapy; NCCN, National Comprehensive Cancer Network; EBRT, external beam radiation therapy; GnRH, gonadotropin releasing hormone; PSA, prostate-specific antigen, GI, gastrointestinal; GU, genitourinary.