scholarly journals Results of a Randomized Clinical Trial of the Action of Several Doses of Lycopene in Localized Prostate Cancer: Administration Prior to Radical Prostatectomy

2008 ◽  
Vol 1 ◽  
pp. CMU.S718 ◽  
Author(s):  
Nagi B. Kumar ◽  
Karen Besterman-Dahan ◽  
Loveleen Kang ◽  
Julio Pow-Sang ◽  
Ping Xu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Steroid Hormones ◽  
Controlled Trial ◽  
Antioxidant Properties ◽  
Free Testosterone ◽  
Localized Prostate Cancer ◽  
Ki 67 ◽  
Treatment Groups ◽  
Beneficial Effects ◽  
Prostate Carcinogenesis

Purpose The purpose of this Phase II randomized-controlled trial was to evaluate the safety and effect of administering several doses of lycopene to men with clinically localized prostate cancer, on intermediate endpoint biomarkers implicated in prostate carcinogenesis. Methods Forty-five eligible men with clinically localized prostate cancer were supplemented with 15, 30 or 45 mg of lycopene or no supplement from biopsy to prostatectomy. Compliance to study agent, toxicity, changes in plasma lycopene, serum steroid hormones, PSA and tissue Ki-67 were analyzed from baseline to completion of intervention. Results Forty-two of forty-five five subjects completed the intervention for approximately 30 days from the time of biopsy until prostatectomy. Plasma lycopene increased from baseline to post treatment in all treatment groups with greatest increase observed in the 45 mg lycopene-supplemented arm compared to the control arm without producing any toxicity. Overall, subjects with prostate cancer had lower baseline levels of plasma lycopene similar to those observed in previous studies in men with prostate cancer. Serum free testosterone decreased with 30 mg lycopene supplementation and total estradiol increased significantly with 30 mg and 45 mg supplementation from baseline to end of treatment, with no significant increases in serum PSA or tissue Ki-67. These changes were not significant compared to the control arm for this sample size and duration of intervention. Conclusions Although antioxidant properties of lycopene have been hypothesized to be primarily responsible for its beneficial effects, our study suggests that other mechanisms mediated by steroid hormones may also be involved.

scholarly journals Phase II, Randomized, Placebo-Controlled Trial of Neoadjuvant Celecoxib in Men With Clinically Localized Prostate Cancer: Evaluation of Drug-Specific Biomarkers

2009 ◽  
Vol 27 (30) ◽  
pp. 4986-4993 ◽  
Author(s):  
Emmanuel S. Antonarakis ◽  
Elisabeth I. Heath ◽  
Janet R. Walczak ◽  
William G. Nelson ◽  
Helen Fedor ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Controlled Trial ◽  
Clinical Stage ◽  
Specific Antigen ◽  
Prostate Tissue ◽  
Localized Prostate Cancer ◽  
Double Blind ◽  
Ki 67 ◽  
End Points ◽  
Cox 2

Purpose Cyclooxygenase-2 (COX-2) is a potential pharmacologic target for the prevention of various malignancies, including prostate cancer. We conducted a randomized, double-blind trial to examine the effect of celecoxib on drug-specific biomarkers from prostate tissue obtained at prostatectomy. Patients and Methods Patients with localized prostate cancer and Gleason sum ≥ 7, prostate-specific antigen (PSA) ≥ 15 ng/mL, clinical stage T2b or greater, or any combination with greater than 45% risk of capsular penetration were randomly assigned to celecoxib 400 mg by mouth twice daily or placebo for 4 to 6 weeks before prostatectomy. The primary end point was the difference in prostatic prostaglandin levels between the two groups. Secondary end points were differences in COX-1 and -2 expressions; oxidized DNA bases; and markers of proliferation, apoptosis and angiogenesis. Tissue celecoxib concentrations also were measured. Tertiary end points were drug safety and compliance. Results Seventy-three patients consented, and 64 were randomly assigned and included in the intention-to-treat analysis. There were no treatment differences in any of the primary or secondary outcomes. Multivariable regression revealed that tumor tissue had significantly lower COX-2 expression than benign prostatic tissue (P = .01) and significantly higher levels of the proliferation marker Ki-67 (P < .0001). Celecoxib was measurable in prostate tissue of patients on treatment, demonstrating that celecoxib reached its target. Celecoxib was safe and resulted in only grade 1 toxicities. Conclusion Treatment with 4 to 6 weeks of celecoxib had no effect on intermediate biomarkers of prostate carcinogenesis, despite the achievement of measurable tissue levels. We caution against using celecoxib 400 mg twice daily as a preventive agent for prostate cancer in additional studies.

1141: A Randomized Controlled Trial Comparing External Beam Radiation and Cryoablation in Localized Prostate Cancer

2007 ◽  
Vol 177 (4S) ◽  
pp. 376-377 ◽  
Author(s):  
Bryan J. Donnelly ◽  
John C. Saliken ◽  
Penny Brasher ◽  
Scott Ernst ◽  
Harold Lau ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Localized Prostate Cancer ◽  
External Beam Radiation ◽  
External Beam ◽  
Beam Radiation ◽  
Randomized Controlled

scholarly journals Survival and mortality of elderly men with localized prostate cancer managed with primary androgen deprivation therapy or by primary observation

2020 ◽  
Author(s):  
Heikki Seikkula ◽  
Peter J. Boström ◽  
Karri Seppä ◽  
Janne Pitkäniemi ◽  
Nea Malila ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Androgen Deprivation Therapy ◽  
Androgen Deprivation ◽  
Localized Prostate Cancer ◽  
Curative Treatment ◽  
Entire Study ◽  
Treatment Groups ◽  
Age Cohorts ◽  
Cancer Aggressiveness

Abstract Background: Androgen deprivation therapy (ADT) remains a primary treatment for localized prostate cancer (PCa) even though there is no evidence that its use is beneficial in the absence of curative treatment.Methods: Men aged ≥70 years (n = 16534) diagnosed with localized PCa from 1985 to 2014 and managed either with primary observation or ADT in the absence of curative treatment were included. The cases were identified from the population-based Finnish Cancer Registry. We estimated the standardized mortality ratios (SMR) for overall mortality by treatment group. We determined the relative risk (RR) of PCa-specific mortality (PCSM) and other-cause mortality between the two treatment groups. Survival was determined using the life table method. Two age groups (70–79 years and ≥80 years) and three calendar time cohorts (1985–1994, 1995–2004, and 2005–2014) were compared following adjustment of propensity score matching between the treatment groups with four covariates (age, year of diagnosis, educational level, and hospital district). Follow-up continued until death or until December 31, 2015. Results: Patients in the observation group had lower overall SMRs than those in the ADT group in both age cohorts over the entire study period. PCSM was higher in men aged 70–79 years undergoing primary ADT compared to those managed by observation only (RR: 1.70, 95% confidence interval [CI]: 1.29–2.23 [1985–1994]; RR 1.55, 95% CI: 1.35–1.84 [1995–2004]; and RR 2.71, 95% CI: 2.08–3.53 [2005–2014]); p = 0.005 for periodic trend. A similar trend over time was also observed in men aged >80 years; (p for age–period interaction = 0.237). Overall survival was also higher among men in their 70’s managed by observation compared to those undergoing ADT.Conclusions: Primary ADT within four months period from diagnosis is not associated with improved long-term overall survival or decreased PCSM compared to primary conservative management for men with localized PCa. However, this observational study’s conclusions should be weighted with confounding factors related to cancer aggressiveness and comorbidities.

A study of ERG, PTEN, and ki-67 in a phase III trial assessing docetaxel and estramustine in high-risk localized prostate cancer (GETUG 12).

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 5063-5063 ◽  
Author(s):  
Shanna Rajpar ◽  
Philippe Vielh ◽  
Agnes Laplanche ◽  
Francois Lesaunier ◽  
Remy Delva ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Phase Iii ◽  
Localized Prostate Cancer ◽  
Ki 67 ◽  
Phase Iii Trial
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