The Influence of Finasteride on the Development of Prostate Cancer

2021 ◽  
pp. 7-12
Author(s):  
Niranjan Sathianathen
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Oncological Outcomes ◽  
Prostate Cancer Prevention ◽  
Secondary Analyses ◽  
High Risk Cancer ◽  
Medicare Claims Data ◽  
Major Reduction ◽  
Disease Specific

This chapter describes the design, main findings, relevance, and limitations of the landmark Prostate Cancer Prevention Trial (PCPT), which randomized men to finasteride versus placebo and followed them for 7 years. It found a major reduction in prostate cancer incidence but also a higher proportion of high-risk cancer in men diagnosed with prostate cancer. The study did not address the more important oncological outcomes of disease-specific and overall survival. Secondary analyses of PCPT outcomes favored the finasteride arm and suggested that the risk of high-risk cancer is not increased. Linkage analysis of participants from PCPT to Medicare claims data suggested no adverse long-term cardiac, endocrine, or sexual effects.

Duration of androgen deprivation therapy in high-risk prostate cancer: A randomized trial.

2013 ◽  
Vol 31 (18_suppl) ◽  
pp. LBA4510-LBA4510 ◽  
Author(s):  
Abdenour Nabid ◽  
Nathalie Carrier ◽  
André-Guy Martin ◽  
Jean-Paul Bahary ◽  
Luis Souhami ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Survival Rates ◽  
Disease Specific Survival ◽  
Cancer Specific Survival ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer ◽  
Disease Specific

LBA4510 Background: Radiotherapy (RT) and long-term androgen deprivation therapy (ADT) is a standard treatment for patients with high-risk prostate cancer. However, the optimal duration of ADT is not yet defined. The purpose of this randomized trial was to compare outcomes between 36 and 18 months of ADT in high-risk prostate cancer treated with RT (PCS IV trial). Methods: PCS IV randomized patients with node-negative high-risk prostate cancer (T3-4, PSA >20 ng/ml or Gleason score >7), to pelvic RT (whole pelvis 44 Gy/4 ½ weeks, prostate 70 Gy/7 weeks) and 36 (arm 1) vs 18 months (arm 2) of ADT (neo- adjuvant, concomitant, adjuvant). ADT consisted of bicalutamide 50 mg for one month and goserelin 10.8 mg every three months for 36 vs 18 months. Overall survival was the primary end point. From randomization, overall and cancer-specific survival rates were compared between arms with Kaplan-Meier log rank test and Cox regression. Results: From October 2000 to January 2008, 310 patients were randomized to arm 1 and 320 to arm 2. Patients' characteristics were well balanced between the two arms (median age 71 years, median PSA 16 ng/ml, median Gleason score 8). Most patients had T2-T3 disease. At a median follow-up of 78 months, 80/310 patients (25.8%) in arm 1 and 85/320 (26.6%) in arm 2 had died (p=0.829). 113 patients died of causes other than prostate cancer. Overall and cancer-specific survival hazard ratios were 1.15 (0.85-1.56), p=0.366 and 1.07 (0.62-1.84), p=0.819, respectively. 5-year overall and disease-specific survival rates were 91.1% (87.9-94.3) vs. 86.1% (82.3-90.0), p=0.06 and 96.6% (94.5-98.7) vs. 95.3% (92.8-97.7), p=0.427 and 10-year overall and disease-specific survival rates were 61.9% (54.1-69.7) vs. 58.6% (49.8-67.4), p=0.275 and 84.1% (77.6-90.6) vs. 83.7% (76.3-91.1), p=0.819 for arm 1 and arm 2, respectively. There were no significant differences in the rates of biochemical, regional, or distant failure between arms. Conclusions: With a median follow-up of 6.5 years, our study shows that long-term ADT can be safely reduced from 36 to 18 months without compromising outcomes. Analysis of treatment impact on quality of life is now under review. Source of Funding: AstraZeneca Pharmaceuticals Grant. Clinical trial information: #NCT00223171.

Variation in national use of long-term ADT by disease aggressiveness among men with unfavorable-risk prostate cancer.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 54-54
Author(s):  
Vinayak Muralidhar ◽  
Brandon Arvin Virgil Mahal ◽  
Gally Reznor ◽  
Toni K. Choueiri ◽  
Christopher Sweeney ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Intermediate Risk ◽  
Nccn Guidelines ◽  
High Risk Prostate Cancer ◽  
High Risk Disease ◽  
Risk Prostate Cancer ◽  
High Risk Cancer ◽  
Very High

54 Background: Current National Comprehensive Cancer Network (NCCN) guidelines uniformly recommend long-term androgen deprivation therapy (ADT) for all men with high-risk prostate cancer. We sought to determine whether the use of long-term ADT varied by the subcategory of disease, including the recently-defined subcategories of high-risk disease (favorable, other, and very-high) versus intermediate-risk disease. Methods: We identified 5,836 patients with NCCN intermediate-, high-, or very high-risk prostate cancer diagnosed between 2004 and 2007 and managed with external beam radiation therapy (EBRT) using the Surveillance, Epidemiology, and End Results database linked to Medicare claims data. Patients were stratified by risk group: intermediate-risk, favorable high-risk (previously defined and validated as T1c, Gleason 4+4=8, PSA < 10 ng/mL or T1c, Gleason 6, PSA > 20 ng/mL), other high-risk, or very high-risk. We used competing risks regression to estimate the rates of long-term (≥ 2 years) ADT in each of these groups. Differences were compared using multivariable regression modeling, adjusting for year of diagnosis, race, marital status, income level, age, and comorbidity. Results: Men with favorable high-risk prostate cancer were significantly less likely to receive 2 years of ADT than others with high-risk disease (21.9% vs. 29.3%, adjusted hazard ratio [AHR] 0.78, 95% confidence interval [CI] 0.67-0.90, p = 0.001), and similarly likely as those with intermediate-risk disease (AHR 1.08, 95% CI 0.94-1.25, p = 0.288). Others with high-risk disease were less likely to receive 2 years of ADT than those with very high-risk cancer (29.3% vs 36.4%, AHR 0.84, 95% CI 0.74-0.96, p = 0.010). Conclusions: Patients with EBRT-managed high-risk prostate cancer received significantly different rates of long-course ADT based on subclassification. Despite NCCN guidelines recommending long-term ADT for all high-risk or very high-risk prostate cancer, our results might reflect the view that these patients represent a heterogeneous group, with favorable high-risk cancer possibly warranting less aggressive therapy than other high-risk or very high-risk disease.

High-risk prostate cancer treated with pelvic radiotherapy and 36 versus 18 months of androgen blockade: Results of a phase III randomized study.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 3-3 ◽  
Author(s):  
Abdenour Nabid ◽  
Nathalie Carrier ◽  
André-Guy Martin ◽  
Jean-Paul Bahary ◽  
Luis Souhami ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Randomized Study ◽  
Survival Rates ◽  
Cancer Specific Survival ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer ◽  
Disease Specific ◽  
Androgen Blockade

3 Background: Radiotherapy (RT) and long term androgen blockade (AB) is standard treatment for patients with high risk prostate cancer. However, the optimal duration of AB is not yet defined. The purpose of this randomized study was to compare outcomes between 36 vs. 18 months of AB in high risk prostate cancer treated with RT (PCS IV trial, Clinical Trials.gov, #NCT00223171). Methods: PCS IV randomized patients with node negative high risk prostate cancer (T3-4, PSA >20 ng/ml or Gleason score >7), to pelvic RT (whole pelvis 44 Gy/4 ½ weeks, prostate 70 Gy/7 weeks) and 36 (arm 1) vs. 18 months (arm 2) of AB (neo adjuvant, concomitant, adjuvant). AB consisted of bicalutamide 50 mg for one month plus goserelin 10.8 mg every three months for 36 vs. 18 months. Overall survival was the primary end point. Overall and cancer specific survival rates were compared between arms with Kaplan-Meier log rank test and Cox regression. Results: From October 2000 to January 2008, 310 patients were randomized to arm 1 and 320 to arm 2. Patients’ characteristics were well balanced between the two arms (median age 71 years, median PSA 16 ng/ml, median Gleason score 8). Most patients had T2-3 disease. At a median follow-up of 77 months, 71/310 patients (22.9%) in arm 1 and 76/320 (23.8%) in arm 2 had died (p=0.802). Overall, 116 patients died of causes other than prostate cancer. Overall and cancer specific survival hazard ratios were 1.15 (0.83-1.59), p=0.398 and 1.13 (0.61-2.08), p=0.153, respectively. 5 year overall and disease specific survival rates were 92.1% (89.1-95.1) vs. 86.8% (83.0-90.6), p=0.052 and 97.6% (95.9-99.4) vs. 96.4% (94.2-98.6), p=0.473 and 10 year overall and disease specific survival rates were 63.6% (55.7-71.5) vs. 63.2% (54.7-71.7), p=0.429 and 87.2% (81.0-93.3) vs. 87.2% (80.9-93.6), p=0.838 for arm 1 and arm 2, respectively. There were no significant differences in the rates of biochemical, regional or distant failure between arms. Conclusions: Our study shows that long term AB can be safely reduced from 36 to 18 months without compromising outcomes. Analysis of treatment impact on quality of life is now under review. Source of Funding: AstraZeneca Pharmaceuticals Grant. Clinical trial information: Clinical Trials.gov, #NCT00223171.

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