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


N/A
50 Years
75 Years
Not Enrolling
Male
Early Detection of Cancer

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Trial Information

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


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 4 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.


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.

Group 3--subjects in the dutasteride treatment group who did not meet any of the 4
dutasteride criteria (ie, dutasteride subjects not in Group 1e).

Group 4--subjects in the placebo treatment group who did not meet any of the 7 placebo
criteria (ie, placebo subjects not in Group 2h).

Type of Study:

Observational

Study Design:

Time Perspective: Retrospective

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Stephen Jones, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Institutional Review Board

Study ID:

REDUCE-FOR CAUSE

NCT ID:

NCT01529086

Start Date:

February 2012

Completion Date:

February 2012

Related Keywords:

  • Early Detection of Cancer
  • prostate cancer
  • dutasteride
  • for cause prostate biopsy

Name

Location

Cleveland ClinicCleveland, Ohio  44195