Publications

Publications

Intermittent versus continuous androgen deprivation in prostate cancer.

By:
Contributors: Bryan Donnelly, MD, MSc, FRCSC, Peter Venner, MD, FRCPC
Urol Oncol. 2014 Aug;32(6):936-7. doi: 10.1016/j.urolonc.2014.01.009.

Abstract

BACKGROUND:

Castration resistance occurs in most patients with metastatic hormone-sensitive prostate cancer who are receiving androgendeprivation therapy. Replacing androgens before progression of the disease is hypothesized to prolong androgen dependence.

METHODS:

Men with newly diagnosed, metastatic, hormone-sensitive prostate cancer, a performance status of 0 to 2, and a prostate-specific antigen (PSA) level of 5 ng per milliliter or higher received a luteinizing hormone-releasing hormone analogue and an antiandrogen agent for 7 months. We then randomly assigned patients in whom the PSA level fell to 4 ng per milliliter or lower to continuous or intermittent androgen deprivation, with patients stratified according to prior or no prior hormonal therapy, performance status, and extent of disease (minimal or extensive). The coprimary objectives were to assess whether intermittent therapy was noninferior to continuous therapy with respect to survival, with a one-sided test with an upper boundary of the hazard ratio of 1.20, and whether quality of life differed between the groups 3 months after randomization.

RESULTS:

A total of 3040 patients were enrolled, of whom 1535 were included in the analysis: 765 randomly assigned to continuous androgen deprivation and 770 assigned to intermittent androgen deprivation. The median follow-up period was 9.8 years. Median survival was 5.8 years in the continuous-therapy group and 5.1 years in the intermittent-therapy group (hazard ratio for death with intermittent therapy, 1.10; 90% confidence interval, 0.99 to 1.23). Intermittent therapy was associated with better erectile function and mental health (P<0.001 and P=0.003, respectively) at month 3 but not thereafter. There were no significant differences between the groups in the number of treatment-related high-grade adverse events.

CONCLUSIONS:

Our findings were statistically inconclusive. In patients with metastatic hormone-sensitive prostate cancer, the confidence interval for survival exceeded the upper boundary for noninferiority, suggesting that we cannot rule out a 20% greater risk of death with intermittent therapy than with continuous therapy, but too few events occurred to rule out significant inferiority of intermittent therapy. Intermittent therapy resulted in small improvements in quality of life. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00002651.).

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ClarityDX Prostate clinical study expanding to the United States

Oct 8, 2019: APCaRI and Nanostics Inc. are excited to announce the opening of the first recruitment site in the US for the ClarityDX Prostate clinical validation study with Century Clinical Research Inc., based in Daytona Beach, Florida. ClarityDX Prostate is a novel liquid biopsy test for the early diagnosis of clinically significant prostate cancer.

The clinical validation study targets the recruitment of 2,800 patients with elevated levels of PSA. Therefore, US recruitment will significantly accelerate the clinical study timeline and increase patient cohort diversity.

Funding support to include US patients comes from the Bird Dogs for Prostate Cancer Research, Alberta Cancer Foundation, Alberta Innovates-ASBIRI program and the University of Alberta. The US and Canadian study samples will continue to be processed in partnership with DynaLIFE Medical Labs in Edmonton, Alberta.

“We’re very happy to partner with Century Clinical Research to recruit US men to our study,” John Lewis, CEO of Nanostics said, “the Florida recruitment site will help us increase the regional diversity of our cohort and strengthen the results of our ClarityDX Prostate study, ultimately, allowing us to make the test available to men across North America.”

“Our extensive clinical trial research experience and diverse patient population in Daytona Beach makes us a perfect partner…” said Thomas Gaskin, Vice-President & CFO of Century Clinical Research, Inc., “we look forward to working with Nanostics to develop their ClarityDX Prostate test to help improve prostate cancer outcomes.”

Implementing ClarityDX Prostate may eliminate up to 600,000 unnecessary biopsies, 24,000 hospitalizations and up to 50% of unnecessary treatments for prostate cancer in North America. This equates to a projected $1.4B per year in cost savings to healthcare and a dramatic impact on the healthcare experience and quality of life for men.

About Century Clinical Research, Inc.
Century Clinical Research, Inc. has over ten years of clinical research experience in multiple specialties, including hematology and oncology. Our staff has completed numerous industry-sponsored clinical trials in phases II-IV and has an excellent track record in quality completion of critical trials. Century Clinical Research, Inc. offers a full research infrastructure and our research staff has been trained in electronic data capture with multiple sponsors. We use a computerized clinical research program for tracking study participation and regulatory documents.
Website: https://www.centuryclinical.com/century_clinical_research.html

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