 |
Table 3. Randomized Controlled Trials Investigating the Use of Neoadjuvant Chemotherapy Prior to Radical Prostatectomy or Adjuvant Chemotherapy Following Radical Prostatectomy in Patients with High-risk Localized Prostate Cancer
| Trial |
Key eligibility criteria |
Randomization |
ADT policy |
RT policy |
Primary end point |
Planned accrual (n) |
| CALGB 90203 NCT00430183 |
Probability of 5-year bPFS = 60% by preoperative Kattan nomogram* |
Neoadjuvant docetaxel x six cycles and concurrent ADT x 18-24 weeks prior to RP versus RP alone |
Neoadjuvant LHRH-a in intervention arm; in RP-alone arm, ADT reserved for PSA failure |
Adjuvant RT for R1 disease at clinician discretion |
bPFS |
700 |
| GETUG 12 NCT00055731 |
At least one of: Gleason = 8 T3 or T4 pre-RP PSA > 20 N1 |
Neoadjuvant docetaxel and estramustine x four cycles prior to local therapy (RP or RT) and ADT x 3 years versus local therapy and ADT x 3 years |
LHRH-a and oral antiandrogen |
Not specified |
bPFS |
250 |
| SPCG-12 NCT00376792 |
Post-RP PSA < 0.5, pN0, and at least one of: pT2 R1 and Gleason 4 + 3 or 8-10 pT3a and Gleason = 4 + 3 pT3b and Gleason = 7 |
Adjuvant docetaxel x six cycles versus observation |
Reserved for PSA failure |
Not specified |
bPFS |
396 |
| SWOG 9921 NCT00004124 |
Post-RP PSA undetectable (=0.2) and at least one of: Gleason = 8 pT3b or pT4 or N1 Gleason 7 and R1 pre-RP PSA > 15 and biopsy Gleason = 8 or pre-RP PSA > 10 and Gleason = 7 |
Adjuvant mitoxantrone and prednisone x six cycles plus ADT x 2 years versus adjuvant ADT alone x 2 years |
Bicalutamide and goserelin in all patients |
Postoperative RT at clinical discretion |
OS |
Closed early after 983 patients accrued (planned accrual: 1360) |
| TAX 3501 (Sanofi-Aventis) NCT00283062 |
Post-RP PSA = 0.2 and probability of 5-year bPFS = 60% by postoperative Kattan nomogram ‡ |
Timing randomization: adjuvant versus early salvage treatment. Treatment randomization: docetaxel x six cycles plus ADT versus ADT alone |
Leuprolide alone |
Postoperative RT not permitted |
bPFS |
Closed early after 216 patients accrued (planned accrual: 1696) |
| VA CSP 553 NCT00132301 |
Post-RP PSA = 0.1, pN0, and at least one of: pT3b or pT4 pT3a and Gleason = 7 pT2 R1 and Gleason 8-10 pre-RP PSA > 20 |
Adjuvant docetaxel and prednisone x six cycles versus observation |
Reserved for PSA failure |
Adjuvant RT forbidden; salvage RT permitted |
bPFS |
636 |
All PSA values are quoted in ng/ml.
*See [16].
‡See [78].
ADT: Androgen-deprivation therapy; bPFS: Biochemical progression-free survival; CALGB: Cancer and Leukemia Group B; GETUG: Groupe d'Étude des Tumeurs Uro-Génitales; LHRH-a: Luteinizing hormone-releasing hormone agonist; OS: Overall survival; PSA: Prostate-specific antigen; RP: Radical prostatectomy; RT: Radiotherapy; SPCG: Scandinavian Prostate Cancer Group; SWOG: Southwest Oncology Group; VA CSP: Veterans Affairs Cooperative Studies Program.
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