Table 1 |.
Cohort sizes and time to publication, and clinical implications of selected phase III trials
| Treatment approach | Number of patients* | Number of centres | Start of accrual | Accrual duration (months) | Months from start of accrual to publication | Supported changes in clinical practice?‡ | Ref. |
|---|---|---|---|---|---|---|---|
| High-risk localized disease | |||||||
| RTOG 0521 (RTfollowed by ADT ± docetaxel) | 282 vs 281 | 12§ | December 2005 | 43.6 | 113.1 | No | 23 |
| GETUG12 (ADT ± docetaxel + estramustine followed by RP/RTfollowed by ADT) | 207 vs 206 | 26 | November 2002 | 48.8 | 149.2 | No | 21 |
| TAX - 3501(RP followed by ADT ± docetaxel) | 70 vs 68 | 108 | December 2005 | 20.8 | 91.6 | No | 69 |
| SWOG S9921 (RP followed by ADT ± mitoxantrone) | 480 vs 481 | NR | October 1999 | 86.2 | 206.3 | No | 24 |
| Locally-advanced disease | |||||||
| RT ± GnRH | 987 vs 992 | 212 | October 1994 | 77.4 | 199.8 | Yes | 108 |
| ADT ± RT | 603 vs 602 | 78 | March 1995 | 124.0 | 189.8 | Yes | 109 |
| ADT ± RT | 436 vs 439 | 47 | February 1996 | 81.3 | 153.2 | Yes | 18 |
| Biochemically recurrent disease | |||||||
| Salvage RT ± anti-androgen | 384 vs 376 | 19§ | March 1998 | 59.5 | 225.2 | Yes | 34 |
| Metastatic castration-sensitive disease | |||||||
| Intergroup (intermittent versus continuous ADT) | 770 vs 765 | 18§ | May 1995 | 158.7 | 213.3 | No | 66 |
| Bilateral orchiectomytflutamide (Ml) | 667 vs 669 | 9§ | December 1989 | 56.5 | 105.4 | No | 37 |
| GETUG 15 (ADT ± docetaxel) | 192 vs 193 | 29§ | October 2004 | 50.0 | 97.9 | No | 49,50 |
| CHAARTED (ADT ± docetaxel) | 397 vs 393 | 15§ | July 2006 | 76.4 | 108.7 | Yes | 44–46 |
| STAMPEDE (ADT ± docetaxel) | 727 vs 1,090 | 125 | October 2005 | 89.1 | 121.5 | Yes | 47,48 |
| LATITUDE (ADT ± abiraterone) | 597 vs 602 | 235 | February 2013 | 21.8 | 31.2 | Yes | 51 |
| STAMPEDE (ADT ± abiraterone) | 500 vs 502 | 116 | November 2011 | 25.9 | 66.1 | Yes | 52 |
ADT, androgen deprivation therapy; GnRH, gonadotrophin-releasing hormone; NR, not reported; RP, radical prostatectomy; RT, radiotherapy.
*
First number represents the number of patients assigned to the experimental arm, followed by the number assigned to the control arm.
‡
Refers to study results that lead to incorporation within National Comprehensive Cancer Network guidelines.
§
Estimated, based upon number of investigators.