Study | Patients with PCa | N (ITT) | PSA levels (ng/ml) | Primary endpoint | Median follow-up (years) | |
---|---|---|---|---|---|---|
Cease treatment | Restarted treatment | |||||
Recurrent (after radiotherapy) | 1386 | <4 and not > 1 above the previous recorded value as monitored | >10 | OS | 6.9 | |
Locally advanced, metastatic | 626 | <4 ≤80% initial level | ≥10 (symptomatic) or ≥20 (asymptomatic) ≥20% above nadir value | TTP | 4.75 | |
Metastatic | 1535 | ≤4 | ≥20 or ≥10 or symptoms | OS | 9.2 | |
Locally advanced, metastatic or recurrent (after radiotherapy or prostatectomy) | 554 | <10 >50% (PSA < 20) | PSA or CP | TTP | 5.4 | |
Recurrent (after prostatectomy) | 201 | ≤0.5 | ≥3 or when was CP | Time to androgen-independent | 2.4 | |
De Leval 2002 [51] | Locally advanced, metastatic or recurrent (after prostatectomy) | 68 | ≤4 | ≥10 | Time to androgen- independent | 2.7 |
Locally advanced or metastatic | 193 | <4 | ≥10 (M0) ≥20 (M1) | TTP | 2.58 | |
Miller 2007 [56] | Locally advanced or metastatic | 335 | <4 | - | TTP | NR |
≤90% initial level | ||||||
Mottet 2012 [50](TAP 22 Trial) | Metastatic and PSA ≥ 20 ng/ml | 173 | < 4 | ≥10 or CP | OS | 3.7 |
Asymptomatic metastatic | 258 | Good or moderate response | PSA or CP | Quality of life | NR | |
Hering 2000 [54] | Metastatic | 43 | 0.4 | ≥10 (initial ≤20) | TTP and adverse events | 4 |
± 50% initial (initial > 20) | ||||||
Irani 2008 [57] | Locally advanced or metastatic | 129 | 6 months | 6 months | Quality of life and TTP | 5 |
Silva 2013 [58](SEUG 9901 Trial) | Locally advanced or metastatic | 918 | < 4 | ≥20 or CP | OS | 5.5 |