Phase III results of adjuvant radiotherapy (RT) versus wait-and-see (WS) in patients with pT3 prostate cancer following radical prostatectomy (RP)(ARO 96–02/AUO AP 09/95)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5060-5060 ◽  
Author(s):  
T. Wiegel ◽  
D. Bottke ◽  
N. Willich ◽  
H. Piechota ◽  
A. Siegmann ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Side Effects ◽  
Radical Prostatectomy ◽  
Gleason Score ◽  
Adjuvant Radiotherapy ◽  
Progressive Disease ◽  
Hormonal Treatment ◽  
Tumor Stage ◽  
Phase Iii ◽  
Phase Iii Study

5060 Background: Adjuvant RT for pT3 R1 or R0 patients (pts.) after RP remains controversial. Results of an EORTC-phase-III- study (with unknown PSA-status after RP) suggested a 20% better biochemical control (bNED) after 5 years for RT. Methods: 385 men with prostate cancer were randomized to either 60 Gy RT (arm A; n=193) or WS (arm B; n=192) before achieving an undetectable PSA. Pts. were stratified for Gleason-score, margin status, neoadjuvant hormonal treatment and stage (pT3A+B vs. C). When the undetectable PSA-level after RP was not achieved, the pts. were stated as progressive disease and left arm A/B and were irradiated. PSA-progression for pts. with undetectable PSA was stated after two consecutive increasing PSA out of the undetectable range. Primary endpoint was bNED. Study was powered to demonstrate a 15% increase in bNED for RT. Results: 78 pts. (20%) did not achieve an undetectable PSA and were stated as progressive disease (arm A: 45 pts., arm B: 33 pts.). Additionally, 34 pts. (23%) from the RT-arm did not receive RT. Therefore, 114 pts. had RT (arm A) and 159 pts. WS (arm B). Median follow up was 53.6 months for arm A and 53.7 months for arm B. BNED at 5 years increased to 72% for arm A (RT) compared with 54% for arm B (WS) (p=0.0015, hazard ratio 0.53). Pts. with a preop. PSA > 10 ng/ml, tumor stage =pT3b, Gleason score =8 as well as positive margins profited significantly from adjuvant RT. The rate of late grade II side effects for the rectum was 1%. Conclusions: Adjuvant radiotherapy for pT3 prostate cancer significantly reduces the risk of biochemical progression after radical prostatectomy. The rate of side effects is very low. No significant financial relationships to disclose.

Phase III results of adjuvant radiotherapy (RT) versus wait-and-see (WS) in patients with pT3 prostate cancer following radical prostatectomy (RP)(ARO 96-02/AUO AP 09/95): Ten years follow-up.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 4-4 ◽  
Author(s):  
Thomas Wiegel ◽  
Dirk Bottke ◽  
Detlef Bartkowiak ◽  
Claudia Bronner ◽  
Ursula Steiner ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Progressive Disease ◽  
Hormonal Treatment ◽  
Late Toxicity ◽  
Phase Iii ◽  
Phase Iii Study ◽  
Grade 3 ◽  
Intent To Treat

4 Background: Adjuvant RT for pT3 R1 or R0 patients (pts.) after RP remains controversial. The EORTC-phase-III- study suggested a 20% better biochemical control (bNED) after 10 years for RT but no survival advantage. In contrast, the SWOG trial stated not only a gain in bNED but also an improved metastasis free and overall survival after 12 years follow-up. Now, 10-years results from the ARO 96-02 study are available, which are based on the most precisely defined cohort among the three trials. Methods: 385 men with prostate cancer were randomized to either 60 Gy RT (arm A; n=193) or WS (arm B; n=192) before achieving an undetectable PSA. Pts. were stratified for Gleason-score, margin status, neoadjuvant hormonal treatment and stage (pT3a+b vs. c). When the undetectable PSA-level after RP was not achieved, progressive disease was stated and the pts. left arm A/B. Data analysis was by intent-to-treat (ITT). PSA-progression for pts. with undetectable post-RP PSA was defined as two consecutive increasing PSA. The primary endpoint was bNED. The study was powered to demonstrate a 15% increase in bNED for RT. Results: 78 pts. (20%) did not achieve an undetectable PSA and were stated as progressive disease (arm A: 45 pts., arm B: 33 pts.). Additionally, 34 pts. (23%) from the RT-arm did not receive RT. Therefore, 114 pts. had RT (arm A) and 159 pts. WS (arm B). Median follow up was 111.3 months for arm A and 113.3 months for arm B . bNED at 10 years increased to 56% for arm A (RT) compared with 35% for arm B (WS) (hazard ratio= 0.51; p = 0.00002. Out of 307 ITT pts., 15 died from prostate cancer, 23 for other and 5 for unknown reasons. There was no significant profit from ART regarding the endpoints metastasis-free survival (p=0.56) or overall survival (p=0.59). Worst late side effects to the rectum were two grade 2 cases after ART. Grade ≥2 bladder toxicity occurred in 4 out of 148 ITT pts. No grade 4 events were reported. Conclusions: With only one grade 3 case of late toxicity, ART was safe in pT3 prostate cancer. At 10 years median follow up, it reduced the risk of bNED by 49%. The study was not powered to detect differences in OS. Clinical trial information: ARO 96-02/AUO AP 09/95.

Patterns of referral for adjuvant radiotherapy after radical prostatectomy in men with prostate cancer: A population-based analysis.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 140-140
Author(s):  
Harvey Quon ◽  
Derek Suderman ◽  
Kimi Guilbert ◽  
Pascal Lambert
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Gleason Score ◽  
Odds Ratio ◽  
Adjuvant Radiotherapy ◽  
Randomized Trials ◽  
Radiation Oncologist ◽  
Before And After ◽  
Margin Positive

140 Background: Randomized trials have shown improved biochemical disease free survival after adjuvant radiotherapy (ART) in patients with pT3 or margin positive disease after radical prostatectomy for prostate cancer. This study examines the rates of referral to a radiation oncologist for patients with high risk pathologic features after prostatectomy. Also, the impact of the presentation of these randomized trials will be examined. Methods: All men diagnosed in the province of Manitoba with prostate adenocarcinoma between 2003 and 2008 who underwent radical prostatectomy were identified through a central cancer registry database. Manual chart review was performed and detailed demographic and clinico-pathologic data were analyzed to determine their influence on referral to a radiation oncologist within 6 months of surgery. Analysis of referral rates before and after the presentation of 2 randomized trials were also examined. Results: A total of 1080 patient records of men undergoing prostatectomy for prostate cancer were reviewed. Of these, 546 (50.6%) men had at least one high risk pathologic feature. This includes pT2 margin positive disease in 298/546 (54.6%), pT3a in 154/546 (28.2%), and pT3b in 94/546 (17.2%). Multivariable logistic regression was performed adjusting for age, distance from cancer centre, Gleason score, T stage, perineural invasion, and margin status. Gleason score 8-10 (p<0.0001), higher pathologic T stage (p<0.0001), and farther distance (p=0.0028) were associated with referral for ART. Age and margin status were not significantly associated. Men with pT3a (odds ratio 3.35) and pT3b disease (odds ratio 5.32) were more likely to be referred than pT2 margin positive disease (p<0.0001). There were 78/546 (14.3%) patients with a high risk factor who were referred for ART within 6 months of surgery. The rates of referral were not significantly different before and after the presentation of randomized trials (p=0.60). Conclusions: Men with higher pathologic stage (pT3) and grade (Gleason 8-10) are more likely to receive ART. However, referral for ART did not increase significantly after presentation of the randomized trials and remains underutilized.

Phase III Postoperative Adjuvant Radiotherapy After Radical Prostatectomy Compared With Radical Prostatectomy Alone in pT3 Prostate Cancer With Postoperative Undetectable Prostate-Specific Antigen: ARO 96-02/AUO AP 09/95

2009 ◽  
Vol 27 (18) ◽  
pp. 2924-2930 ◽  
Author(s):  
Thomas Wiegel ◽  
Dirk Bottke ◽  
Ursula Steiner ◽  
Alessandra Siegmann ◽  
Reinhard Golz ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radical Prostatectomy ◽  
Prostate Specific Antigen ◽  
Adjuvant Radiotherapy ◽  
Specific Antigen ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Free Survival ◽  
Wait And See ◽  
Biochemical Progression

Purpose Local failure after radical prostatectomy (RP) is common in patients with cancer extending beyond the capsule. Two randomized trials demonstrated an advantage for adjuvant radiotherapy (RT) compared with a wait-and-see policy. We conducted a randomized, controlled clinical trial to compare RP followed by immediate RT with RP alone for patients with pT3 prostate cancer and an undetectable prostate-specific antigen (PSA) level after RP. Methods After RP, 192 men were randomly assigned to a wait-and-see policy, and 193 men were assigned to immediate postoperative RT. Eligible patients had pT3 pN0 tumors. Patients who did not achieve an undetectable PSA after RP were excluded from treatment according to random assignment (n = 78; 20%). Of the remaining 307 patients, 34 patients on the RT arm did not receive RT and five patients on the wait-and-see arm received RT. Therefore, 114 patients underwent RT and 154 patients were treated with a wait-and-see policy. The primary end point was biochemical progression-free survival. Results Biochemical progression-free survival after 5 years in patients with undetectable PSA after RP was significantly improved in the RT group (72%; 95% CI, 65% to 81%; v 54%, 95% CI, 45% to 63%; hazard ratio = 0.53; 95% CI, 0.37 to 0.79; P = .0015). On univariate analysis, Gleason score more than 6 and less than 7, PSA before RP, tumor stage, and positive surgical margins were predictors of outcome. The rate of grade 3 to 4 late adverse effects was 0.3%. Conclusion Adjuvant RT for pT3 prostate cancer with postoperatively undetectable PSA significantly reduces the risk of biochemical progression. Further follow-up is needed to assess the effect on metastases-free and overall survival.

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