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Completed

NCT Number: NCT01529086

For Cause Prostate Biopsy in REDUCE Population Trial

The REDUCE trial was conducted to determine whether dutasteride reduces the risk of incident prostate cancer, as detected on biopsy, among men who are at increased risk for the disease. Dutasteride was compared with placebo for 4 years period. Results showed a relative risk reduction of 22.8 % (95% CI: 15.2 to 29.8)in prostate cancer.

For REDUCE, biopsies were defined as "protocol biopsy" if performed at certain timeframes, and "for cause" if outside these predetermined timeframes.

The investigators propose a post hoc analysis that would allow them to include biopsies that really justified a clinical indication, but were excluded from "for cause" analysis based on occurring at either the 2 or 4 year timeframes.

Thus the investigators propose analysis of both REDUCE groups by every yearly timeframe as:

Group 1--dutasteride group biopsied "for cause" using several definitions: biopsy of patients who received dutasteride whose PSA rose from nadir as defined in your own protocol,who had a PSA rise>0.2 ng/ml or who had a new abnormal DRE or had a free PSA<12% . The investigators define these as such because this would reasonably instigate biopsy if the clinician had a patient with this scenario in the non-study setting.

Group 2--placebo group biopsied "for cause" using several definitions, regardless of timeframe but reported at each year of the study and aggregate, with the aggregate number being the primary outcome. Thus the investigators would request results of biopsy of patients who received placebo To establish differences in biopsy positive rates the groups as per each definition listed, to determine if dutasteride decreased the likelihood of "for cause" biopsy compared to "not for cause" biopsy, and if there is a difference in cancer detection risk rate depending on cause vs. no cause in that group compared to placebo.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

Purpose: Determining the likelihood of prostate cancer detection in men taking dutasteride when biopsy is performed 'for cause'.

Population: The population of interest is the REDUCE Biopsied population, that is, all subjects in the Efficacy population who have at least one post-baseline biopsy reviewed by the Central Pathology Laboratory.

Analyses: Initial interest will be focused on data from the Year 1-2 time period, to avoid the potential effect of the cancer diagnoses from the Year 2 scheduled biopsies on the assessments utilized in the "for cause" definitions. Only PSA data from Years 1-2 and baseline will be utilized in the computation of the various PSA metrics, and only Central Pathology results from Years 1-2 will be utilized to establish post-baseline diagnoses. PSA values on or within 42 days after date of biopsy will be excluded from the analyses, to avoid potential effects of biopsy on the PSA value.

For each of the 2 groups of subjects, the following will be summarized: number of subjects meeting the corresponding criteria, number and % of subjects diagnosed with prostate cancer, number and % of such subjects diagnosed with Gleason 7-10, and number and % of subjects diagnosed with either prostate cancer, HGPIN or ASAP. Summaries of the numbers of subjects meeting each of the specific criteria for group 1 (a through e) and Group 2 (a through h) will be provided.

In addition, summaries investigating the effect of baseline variables (such as age, family history of prostate cancer, prostate volume, percent free PSA, number of cores at the entry biopsy) on the occurrence of prostate cancer diagnoses and Gleason 7-10 diagnoses may be developed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Group 1-subjects in the dutasteride treatment group who meet the following sets of criteria:

  • A rise in PSA from nadir at any time post-nadir
  • PSA change from baseline >0.2 ng/ml at any time post-baseline
  • Abnormal DRE at any time post-baseline
  • Free PSA<12% at any time post-baseline
  • At least one of the above 4 criteria.

Group 2-subjects in the placebo treatment group who meet the following sets of criteria:

  • Change from baseline PSA between 0.0 and 0.35 (ie, 0.0 ≤ change from baseline PSA < 0.35) at any time post-baseline. Note that in REDUCE PSA was recorded to the nearest 0.1.
  • Abnormal DRE at any time post-baseline
  • Change from baseline PSA ≥ 0.35 at any time post-baseline
  • Change from baseline PSA ≥ 0.75 at any time post-baseline
  • PSA ≥ 2.5 at any time post-baseline
  • PSA ≥ 4.0 at any time post-baseline
  • Percent Free PSA < 12% at any time post-baseline
  • At least one of the above 7 criteria.

Treatment and study plan

Primary outcomes

  1. Cancer detection risk among the groups in the "for cause" context

    Time frame: 4 years

    Determination of differences in cancer detection risk rate depending on cause vs no cause in that group compared to placebo

Secondary outcomes

  1. Dutasteride as a key factor in the likelihood of "for cause" biopsy

    Time frame: 4 years

    Determination of dutasteride as an item in decreasing the likelihood of "for cause" biopsy compared to "not for cause" biopsy

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Determining the Likelihood of Prostate Cancer Detection in Men Taking Dutasteride When Biopsy is Performed 'for Cause'.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2012
Registry last updated
Aug 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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