NCT00668642

Brief Summary

The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Mar 2007

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
10.3 years until next milestone

Results Posted

Study results publicly available

August 22, 2023

Completed
Last Updated

August 22, 2023

Status Verified

July 1, 2023

Enrollment Period

6.2 years

First QC Date

April 28, 2008

Results QC Date

January 8, 2023

Last Update Submit

July 26, 2023

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle.

    Calculation of the level of gene expression of the U19 tumor suppressor gene compared between the 2 arms at the end of "off-treatment" cycle 1.

    At the end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months)

Secondary Outcomes (1)

  • Determination of Prostate-specific Antigen (PSA) Doubling Time During First Off-cycle

    At month 9 and ongoing monthly until end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months)

Study Arms (2)

A: Dutasteride During First Off-Cycle

EXPERIMENTAL

Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle

Drug: Dutasteride

B: Placebo During First Off-Cycle

PLACEBO COMPARATOR

Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle

Drug: Placebo

Interventions

DutasterideDRUG

0.5 mg capsule given orally on daily basis

Also known as: Avodart
A: Dutasteride During First Off-Cycle
PlaceboDRUG

Identical placebo

B: Placebo During First Off-Cycle

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven prostate cancer
  • Patients are hormone-naive
  • Patients either to begin androgen ablation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or already receiving therapy with LHRH agonist
  • Advanced prostate cancer with either positive pelvic nodes or bone/visceral metastasis
  • Must have an intact prostate (no previous surgery or XRT)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Recovery from any major infection or surgical procedure
  • Signed informed consent

You may not qualify if:

  • Known intolerance or allergy to dutasteride
  • Concomitant chemotherapy, biologic therapy, or XRT to prostate
  • Bilateral orchiectomy
  • Prior malignancy within 5 years of registration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Northwestern University Medical Center

Chicago, Illinois, 60611, United States

Location

University of Chicago Hospitals and Clinics

Chicago, Illinois, 60637, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AzasteroidsSteroids, HeterocyclicSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Daniel Shevrin
Organization
Northshore University Healthsystem
Dshevrin@northshore.org
847-570-2515

Study Officials

  • Daniel H Shevrin, MD

    Endeavor Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Division of Hematology/Oncology

Study Record Dates

First Submitted

April 28, 2008

First Posted

April 29, 2008

Study Start

March 1, 2007

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 22, 2023

Results First Posted

August 22, 2023

Record last verified: 2023-07

Locations

US(3)