Patients’ self-assessment versus investigators’ evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15)

2014 ◽  
Vol 50 (5) ◽  
pp. 953-962 ◽  
Author(s):  
Gwenaelle Gravis ◽  
Patricia Marino ◽  
Florence Joly ◽  
Stéphane Oudard ◽  
Franck Priou ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Metastatic Prostate Cancer ◽  
Phase Iii ◽  
Self Assessment ◽  
Phase Iii Trial

scholarly journals Phase III Trial of Androgen Ablation With or Without Three Cycles of Systemic Chemotherapy for Advanced Prostate Cancer

2008 ◽  
Vol 26 (36) ◽  
pp. 5936-5942 ◽  
Author(s):  
Randall E. Millikan ◽  
Sijin Wen ◽  
Lance C. Pagliaro ◽  
Melissa A. Brown ◽  
Brenda Moomey ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Specific Antigen ◽  
Standard Therapy ◽  
Metastatic Prostate Cancer ◽  
Specific Antigen ◽  
Hormone Treatment ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Androgen Ablation ◽  
Castrate Resistant

Purpose We conducted a phase III trial in patients with previously untreated metastatic prostate cancer to test the hypothesis that three 8-week cycles of ketoconazole and doxorubicin alternating with vinblastine and estramustine, given in addition to standard androgen deprivation, would delay the appearance of castrate-resistant disease. Patients and Methods Eligible patients had metastatic prostate cancer threatening enough to justify sustained androgen ablation and were fit enough for chemotherapy. The primary end point was time to castrate-resistant progression as shown by increasing prostate-specific antigen, new radiographic lesions, worsening cancer-related symptoms, or receipt of any other systemic therapy. Results Three hundred six patients were registered; 286 are reported. Median time to progression was 24 months (95% CI, 18 to 39 months) in the standard therapy arm, and 35 months (95% CI, 26 to 44 months) in the chemohormonal group (P = .39). At median follow-up of 6.4 years, overall survival was 5.4 years (95% CI, 4.7 to 7.8 years) in the standard therapy arm versus 6.1 years (95% CI, 5.1 to 10.1 years; P = .41). Prostate-specific antigen kinetics at the time of androgen ablation and the nadir after hormone treatment were strongly correlated with survival. Chemotherapy significantly increased the burden of therapy, with 51% of patients experiencing an adverse event of grade 3 or worse, especially thromboembolic events. Conclusion There is no role for ketoconazole and doxorubicin alternating with vinblastine and estramustine before emergence of a castrate-resistant phenotype.

Safety results of a phase III trial evaluating ADT+ docetaxel versus ADT alone in hormone-naïve metastatic prostate cancer patients (GETUG-AFU 15/0403).

2010 ◽  
Vol 28 (15_suppl) ◽  
pp. 4681-4681 ◽  
Author(s):  
I. Latorzeff ◽  
B. Esterni ◽  
M. Habibian ◽  
G. Delplanque ◽  
C. Theodore ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Patients ◽  
Metastatic Prostate Cancer ◽  
Phase Iii ◽  
Phase Iii Trial

Androgen deprivation therapy (ADT) plus docetaxel (D) versus ADT alone for hormone-naïve metastatic prostate cancer (PCa): Long-term analysis of the GETUG-AFU 15 phase III trial.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 140-140 ◽  
Author(s):  
Gwenaelle Gravis ◽  
Jean-Marie Boher ◽  
Florence Joly ◽  
Stephane Oudard ◽  
Laurence Albiges ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Metastatic Prostate Cancer ◽  
High Volume ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Intention To Treat ◽  
Original Analysis ◽  
Definition Of

140 Background: ADT is standard treatment for metastatic PCa. Recently, the E3805 trial reported a survival benefit for (ADT+D) in high volume disease (HVD) patients, whereas the GETUG-15 trial did not demonstrate a survival improvement among a less selected group of patients (pts) with hormone-naïve metastatic PCa. We report an updated analysis of overall survival (OS) of the GETUG 15 trial and aligned the definition of HVD and low volume disease (LVD) subgroups. Methods: Long-termOS was analyzed in the intention-to-treat population (n=385 pts). Additionally, we retrospectively assessed the tumor volume as defined per E3805criteria in all patients enrolled in GETUG 15. Results: See Table. With a median follow-up of 82.9 months (95%CI [80.5-84.3]) (vs 50 months (95%CI [80.5-84.3] in the original analysis), 212 patients (55%) have died. The median OS is 46.5 [39.1-60.6] and 60.9 months [46.1-71.4] in the ADT and in the ADT + D arms, respectively (HR: 0.9 [95%CI: 0.7-1.2]). In HVD patients (n=183, 47.5%), median OS rates were 35.1 months [29.9-44.2] in the ADT alone arm and 39 months [28-52.6] in the ADT+D arm (HR: 0.8 [0.6-1.2]). Conclusions: With longer follow-up, the addition of docetaxel to ADT did not significantly improve OS in patients with hormone-naïve metastatic prostate cancer. In the retrospective analysis using aligned definition of volume of metastasis as E3805, the HVD outcomes were similar to E3805 for ADT alone and there was a non-significant 4 months increase in OS with ADT+D, in this underpowered subset. Clinical trial information: 00104715. [Table: see text]

PSA response and early PSA progression evaluated in patients randomized in a phase III trial comparing androgen-deprivation therapy (ADT) plus docetaxel versus ADT alone in hormone-naive metastatic prostate cancer (GETUG-AFU 15/0403).

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 10-10 ◽  
Author(s):  
G. Gravis ◽  
K. Fizazi ◽  
F. Joly ◽  
S. Oudard ◽  
F. Priou ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Androgen Deprivation Therapy ◽  
Metastatic Prostate Cancer ◽  
Multicentre Trial ◽  
Strong Predictor ◽  
Androgen Deprivation ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Psa Response ◽  
Psa Progression

10 Background: Androgen deprivation therapy (ADT) is the standard treatment of hormone naïve metastatic prostate cancer (HNMPC). We initiated a phase III multicentre trial comparing ADT with or without docetaxel (D) in HNMPC (GETUG 15) and the primary endpoint is overall survival. PSA progression defined as an increase of 25% over baseline or nadirin the first 7 months was recently shown to be a strong predictor of death in HNMPC (Hussain M et al J Clin Oncol 27: 2009). Methods: Patients (pts) with HNMPC were randomly assigned to either arm A (ADT plus D: 75mg/m2 q3w, 9 cycles) or arm B (ADT). From 10/2004 to 12/2008, 385 pts were accrued. The median baseline PSA values were 29.4 ng/mL (0.05-2,170) in arm A and 25.3 ng/mL (0.1-11,900) in arm B. Data on PSA response are available in 171/192 pts (arm A) pts and 181/193 pts (arm B) at 3 months and 156 pts (arm A) and 148 pts (arm B) at 6 months. Results: A PSA response (> 30%) was achieved at 3 months in 93.6% (arm A) and 85.1% (arm B; p=0.02). A PSA response (> 50%) was achieved at 3 months in 90.6% (arm A) versus 80.1% (arm B; p=0.01). When assessed at 6 months, a PSA response (> 30%) was obtained in 94.9% (arm A) versus 86.5% (arm B; p=0.02). A PSA response (> 50%) was achieved in 94.9% (arm A) versus 85.8% (arm B; p=0.01) A PSA progression (25% increase) was observed in 1.3% in arm A and 10.1% in arm B (p=0.002). Conclusions: The addition of 3-weekly docetaxel to ADT significantly improves PSA response and significantly reduces PSA progression at 6 months in patients with HNMPC. No significant financial relationships to disclose.

Estimating survival benefit in castrate metastatic prostate cancer: decision making in proceeding to a definitive phase III trial

Urology ◽  
2003 ◽  
Vol 61 (1) ◽  
pp. 142-144 ◽  
Author(s):  
David Andrew Verbel ◽  
W.Kevin Kelly ◽  
Oren Smaletz ◽  
Kevin Regan ◽  
Tracy Curley ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Decision Making ◽  
Survival Benefit ◽  
Metastatic Prostate Cancer ◽  
Phase Iii ◽  
Phase Iii Trial

Intermittent (IAD) versus continuous androgen deprivation (CAD) in hormone sensitive metastatic prostate cancer (HSM1PC) patients (pts): Results of S9346 (INT-0162), an international phase III trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4-4 ◽  
Author(s):  
Maha Hussain ◽  
Catherine M. Tangen ◽  
Celestia S. Higano ◽  
E. David Crawford ◽  
Glenn Liu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Annual Meeting ◽  
Clinical Oncology ◽  
Metastatic Prostate Cancer ◽  
Phase Iii ◽  
Daily News ◽  
Phase Iii Trial ◽  
Online Supplement ◽  
Hormone Sensitive ◽  
Final Text

4 The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Sunday, June 3, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News.

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