Delaying metastatic disease progression in locally advanced disease − Results from the Early Prostate Cancer program at a median follow-up of 7.4 years

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4629-4629 ◽  
Author(s):  
M. P. Wirth ◽  
W. A. See ◽  
D. G. McLeod ◽  
P. Iversen ◽  
T. Morris ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Standard Care ◽  
Advanced Prostate Cancer ◽  
Bone Scan ◽  
Advanced Disease ◽  
Locally Advanced ◽  
Distant Metastases ◽  
Locally Advanced Prostate Cancer ◽  
Locally Advanced Disease

4629 Background: Progression of prostate cancer to bone metastases impacts seriously on patients (pts)’ quality of life and increases treatment costs. The 3rd analysis of the Early Prostate Cancer (EPC) program revealed that bicalutamide (CASODEX) 150 mg plus standard care (radiotherapy [RT], radical prostatectomy [RP] or watchful waiting [WW]) significantly improved progression-free survival (PFS) vs standard care alone in locally advanced disease. Adjuvant bicalutamide 150 mg also improved overall survival for RT pts with locally advanced disease. Here, we report an exploratory analysis of the effect of bicalutamide on delaying bone metastases in pts with locally advanced disease in the EPC program. Methods: The EPC program comprises 3 trials in which pts (n = 8113) were randomized to standard care plus bicalutamide 150 mg or placebo. This exploratory analysis included only pts with locally advanced disease (T3–4, any N; or any T, N+; bicalutamide n = 1367, placebo n = 1315). Distant metastases were assessed by bone scan. Metastatic PFS was defined as time from randomization to either first bone scan-confirmed progression or death in the absence of bone-scan data. A Cox proportional hazards regression model was used for the WW and adjuvant subgroups; each was analyzed separately with covariates for trial, treatment, prior therapy, baseline prostate-specific antigen level, and tumor grade. Results: At 7.4 years’ median follow-up, bicalutamide significantly improved metastatic PFS vs placebo (hazard ratio [HR] 0.64, p < 0.001 for WW; HR 0.77, p = 0.005 for RT/RP; table). The most common adverse events were gynecomastia and breast pain. Conclusion: Addition of bicalutamide 150 mg to standard care significantly reduced the risk of distant metastases in locally advanced prostate cancer, irrespective of standard care. Both the efficacy and tolerability of treatment must be considered, and therefore, bicalutamide is an option for men with locally advanced prostate cancer. [Table: see text] [Table: see text]

Intergroup randomized phase III study of androgen deprivation therapy (ADT) plus radiation therapy (RT) in locally advanced prostate cancer (CaP) (NCIC-CTG, SWOG, MRC-UK, INT: T94-0110; NCT00002633).

2010 ◽  
Vol 28 (18_suppl) ◽  
pp. CRA4504-CRA4504 ◽  
Author(s):  
P. R. Warde ◽  
M. D. Mason ◽  
M. R. Sydes ◽  
M. K. Gospodarowicz ◽  
G. P. Swanson ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Advanced Prostate Cancer ◽  
Locally Advanced ◽  
Phase Iii ◽  
Disease Specific Survival ◽  
Locally Advanced Prostate Cancer ◽  
Combined Modality ◽  
Disease Specific

CRA4504 Background: The impact of radiotherapy on overall survival (OS) in men with locally advanced CaP is unclear. The SPCG-7 trial recently showed a benefit to RT for CaP specific mortality. Our primary objective was to assess the effect of RT on OS when added to lifelong ADT in men with locally advanced CaP. Methods: Patients with T3/T4 (1057) or T2, PSA > 40 μ g/l (119) or T2 PSA > 20 μ g/l and Gleason ≥ 8 (25) and N0 /NX, M0 prostate adenocarcinoma were randomized to lifelong ADT (bilateral orchiectomy or LHRH agonist) with or without RT (65-69 Gy to prostate ± seminal vesicles with or without 45Gy to pelvic nodes). The primary endpoint was OS and secondary endpoints included disease specific survival (DSS), time to disease progression and quality of life. Results: 1205 patients were randomized from 1995 to 2005, 602 to ADT and 603 to ADT+RT (well balanced with respect to baseline characteristics). A protocol specified second interim analysis on OS was performed in Aug 2009 (data cut-off Dec 31 2008). The DSMC recommended release of the results to the Trial Committee for publication. The median follow-up is 6.0 years and 320 patients have died (175 ADT and 145 ADT+RT). 10% of patients had no follow-up data beyond 2006. The addition of RT to ADT significantly reduced the risk of death (hazard ratio [HR] 0.77, 95% CI 0.61-0.98, p=0.033). 140 patients died of disease and/or treatment (89 on ADT and 51 on ADT+RT) The disease specific survival HR was 0.57 (95% CI 0.41-0.81, p=0.001) favoring ADT+RT. The 10 year cumulative disease specific death rates were estimated at 15% with ADT+ RT and 23% with ADT alone. Grade ≥2 late GI toxicity rates were similar in both arms (proctitis, 1.3% ADT alone, 1.8% ADT+RT). Conclusions: The trial results indicate a substantial overall survival and disease specific survival benefit for the combined modality approach (ADT+RT) in the management of patients with locally advanced prostate cancer with no significant increase in late treatment toxicity. In view of this data combined modality therapy (ADT+RT) should be the standard treatment approach for these patients. Supported by NCI-US Grant #5U10CA077202-12, CCSRI Grant #15469. No significant financial relationships to disclose.

Osteopenia (OP) induced by 6 and 18 months androgen deprivation (AD)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5123-5123
Author(s):  
J. Ball
Keyword(s):  
Prostate Cancer ◽  
Bone Mineral ◽  
Gleason Score ◽  
Advanced Prostate Cancer ◽  
Locally Advanced ◽  
Androgen Deprivation ◽  
Locally Advanced Prostate Cancer ◽  
Optimal Duration ◽  
Financial Relationships

5123 Background: In a trial evaluating the optimal duration of AD in locally advanced prostate cancer (PC) we sought to determine whether 18 months of zoledronate (Zd) would reverse AD induced OP and reduce bony failure. Methods: In the four arm 2x2 TROG 03.04 (RADAR) trial, men with T2b,c-4 and T2a (Gleason score >6, PSA >10) N0 M0 PC (but without osteoporosis) were randomised to leuprotide (Lp) 22.5 mgs i.m. 3 monthly for 6 months starting 5 months prior to radiotherapy (RT) in Arm A, or the same treatment with Zd mgs i.v.i. 3 months for 18 months commencing on Day 1 (in Arms B and D), or with Lp 22.5 mg i.m. 3 monthly for 12 months after RT (in Arms C and D). Hip and spinal bone mineral densities (BMD) were measured before treatment (bt) and then at 2 and 4 years using DEXA and differences between trial arms were assessed by paired t tests. OP was defined by T- scores <-1. Results: Between October 2003 and January 2006, 930 men were randomized. 124 men with BMD measures bt and at 2 years are evaluable. Mean change (±SD) in BMD between 0 and 2 years was -0.005 ±0.05 (p=0.57) in Arm A, 0.085 ±0.06 (p=<0.001) in Arm B, 0.054 ±0.07 (p=<0.001) in Arm C, and 0.065 ±0.05 (p=<0.001) in Arm D. 98 men had normal BMD bt. Of these 6 of 51 in Arms A, C (no Zd) have developed OP at 2 years while none of 47 in Arms B, D (+Zd) have as yet. Conclusions: At 2 years OP caused by 6 months AD is minimal, but remains significant after 18 months AD. This is reversed by 18 months Zd, but further follow up will determine whether this degree of OP resolves with time or causes fractures. No significant financial relationships to disclose.

Efficacy of primary hormone therapy for localized or locally advanced prostate cancer: results of a 10-year follow-up

2006 ◽  
Vol 98 (3) ◽  
pp. 573-579 ◽  
Author(s):  
HIDEYUKI AKAZA ◽  
YUKIO HOMMA ◽  
MICHIYUKI USAMI ◽  
YOSHIHIKO HIRAO ◽  
TOMOYASU TSUSHIMA ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Hormone Therapy ◽  
Advanced Prostate Cancer ◽  
Locally Advanced ◽  
Locally Advanced Prostate Cancer

Ten-Year Follow-Up of Radiation Therapy Oncology Group Protocol 92-02: A Phase III Trial of the Duration of Elective Androgen Deprivation in Locally Advanced Prostate Cancer

2008 ◽  
Vol 26 (15) ◽  
pp. 2497-2504 ◽  
Author(s):  
Eric M. Horwitz ◽  
Kyounghwa Bae ◽  
Gerald E. Hanks ◽  
Arthur Porter ◽  
David J. Grignon ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Gleason Score ◽  
Advanced Prostate Cancer ◽  
Locally Advanced ◽  
Androgen Deprivation ◽  
Locally Advanced Prostate Cancer ◽  
End Points

PurposeTo determine whether adding 2 years of androgen-deprivation therapy (ADT) improved outcome for patients electively treated with ADT before and during radiation therapy (RT).Patients and MethodsProstate cancer patients with T2c-T4 prostate cancer with no extra pelvic lymph node involvement and prostate-specific antigen (PSA) less than 150 ng/mL were included. All patients received 4 months of goserelin and flutamide before and during RT. They were randomized to no further ADT (short-term ADT [STAD] + RT) or 24 months of goserelin (long-term ADT [LTAD] + RT). A total of 1,554 patients were entered. RT was 45 Gy to the pelvic nodes and 65 to 70 Gy to the prostate. Median follow-up of all survival patients is 11.31 and 11.27 years for the two arms.ResultsAt 10 years, the LTAD + RT group showed significant improvement over the STAD + RT group for all end points except overall survival: disease-free survival (13.2% v 22.5%; P < .0001), disease-specific survival (83.9% v 88.7%; P = .0042), local progression (22.2% v 12.3%; P < .0001), distant metastasis (22.8% v 14.8%; P < .0001), biochemical failure (68.1% v 51.9%; P ≤ .0001), and overall survival (51.6% v 53.9%, P = .36). One subgroup analyzed consisted of all cancers with a Gleason score of 8 to 10 cancers. An overall survival difference was observed (31.9% v 45.1%; P = .0061), as well as in all other end points herein.ConclusionLTAD as delivered in this study for the treatment of locally advanced prostate cancer is superior to STAD for all end points except survival. A survival advantage for LTAD + RT in the treatment of locally advanced tumors with a Gleason score of 8 to 10 suggests that this should be the standard of treatment for these high-risk patients.

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