Table 3.
Study design of studies comparing intermittent androgen deprivation therapy (IADT) with continuous androgen deprivation therapy (CADT).
| Study | Study design | Patient population | PSA eligibility criteria (ng/mL) | Primary endpoint | Induction therapy | Induction treatment period (month) | PSA criteria for initiating off-treatment period (ng/mL) | PSA level to restart treatment (ng/mL) | Hazard ratio/hypothesis | Assumed median survival/time to progression in CADT arm (year) |
|---|---|---|---|---|---|---|---|---|---|---|
| SEUG 9401 [20] | Superiority trial | Locally advanced or metastatic cancer | ≥4 and <100 | Progression-free survival | LHRH analogue + anti-androgen cyproterone acetate 200 mg/day | 3 | <4, or reduced by at least 80% of initial level by end of induction |
≥10 for symptomatic patients and ≥20 for asymptomatic patients or PSA rose to ≥20% above nadir |
0.70 | 6 (progression-free survival) |
| TULP [24] | NA | Metastatic cancer | NA | Progression-free survival | Busereline 6.6 mg (Suprefact), a 2-monthly subcutaneous depot, and oral nilutamide 300 mg (Anandron) (once a day for the first 4 weeks and 150 mg daily thereafter) |
6 | <4 | M0 at baseline: ≥10; M1 at baseline: ≥20 |
NA | NA |
| Finn Prostate [23] | Superiority trial | Locally advanced or metastatic cancer | M1: any value; M0: ≥60; T3-4M0: ≥20 |
Progression-free survival | LHRH analogue goserelin acetate 3.6 mg subcutaneously every 28 days + cyproterone acetate 100 mg bid during first 12.5 days | 6 | <10, or by >50% if baseline PSA <20 |
>20 or above baseline |
0.74 | 1.7 (progression-free survival) |
| JPR.7 [17] | Non-inferiority trial | Non-metastatic cancer; PSA relapse after radiotherapy | >3 | Overall survival | LHRH agonist + non-steroidal anti-androgen | 8 | <4 and not more than 1 ng/mL above previous recorded value in that treatment cycle | >10 | 1.25 | 7 (overall survival) |
| TAP 22 [22] | Superiority trial | Metastatic cancer | >20 | Overall survival | LHRH agonist leuprorelin sustained release 3.75 mg/month + anti-androgen flutamide 250 mg tablet 3 times daily | 6 | <4 | >10 | 0.51 | 2.5 (overall survival) |
| SEUG 9901 [21] | Non-inferiority trial | Locally advanced or metastatic cancer | ≥4 and ≤ 100 | Overall survival | LHRH agonist triptoreline 11.25 mg + anti-androgen cyproterone acetate 200 mg/day | 3 | <4 | ≥20 | 1.21 | 4.25 (overall survival) |
| SWOG 9346 [25] | Non-inferiority trial | Metastatic, hormone-sensitive cancer | >5 | Overall survival | LHRH agonist + antiandrogen (goserelin and bicalutamide) | 7 | <4 | >20, or Returned to baseline in patients who had PSA <20 before enrollment, or at investigator's discretion could be reinitiated when PSA >10 or symptoms developed |
1.20 | 2.9 (overall survival) |
LHRH, luteinizing hormone–releasing hormone; NA, not available/applicable; PSA, prostate-specific antigen.