Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

Prostate Cancer Clinical Trial

Official title:

Phase II Study of Dutasteride in Prostate Cancer Recurrent During Androgen Deprivation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403000
• Other study ID #: CDR0000514492
• Secondary ID: RPCI-I-34904
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2006
• Last updated: April 30, 2013
• Start date: December 2004
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dutasteride works in treating patients with recurrent prostate cancer that did not respond to androgen-deprivation therapy.

Description:

OBJECTIVES:

Primary

• Evaluate the time to disease progression in patients with recurrent prostate cancer that progressed during androgen-deprivation therapy who are treated with dutasteride.

• Evaluate the toxicity of dutasteride in these patients.

Secondary

• Evaluate the serum prostate-specific antigen (PSA) level and objective radiographic response rate in patients treated with dutasteride.

• Determine the survival of patients treated with dutasteride.

• Determine the quality of life of patients treated with dutasteride.

OUTLINE: Patients receive oral dutasteride once daily until disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 3 months thereafter.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2013
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of prostate cancer

• Asymptomatic progressive disease despite androgen-deprivation therapy

• Progression must occur during androgen-deprivation therapy comprising orchiectomy or luteinizing hormone-releasing hormone (LHRH) analogue with or without antiandrogen AND after antiandrogen withdrawal

• Concurrent LHRH monotherapy (i.e., LHRH analogs, such as leuprolide acetate or goserelin) required in patients who did not undergo prior bilateral orchiectomy to assure testicular androgen suppression

• Recurrent disease, as indicated by at least 1 of the following:

• Prostate-specific antigen (PSA) at baseline = 2.0 ng/mL

• Biopsy-confirmed local recurrence

• Increase in size of measurable lesions on radiographic study

• New lesion on a nuclear bone scan

• Two successive increases in serum PSA measured at least 1 week apart

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy = 12 weeks

• Platelet count = 100,000/mm^3

• Hemoglobin = 9.0 g/dL

• Bilirubin = 2.0 mg/dL

• SGOT = 4 times upper limit of normal

• Creatinine = 2.0 mg/dL

• Fertile patients must use effective contraception during and for 3 months after completion of study therapy

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 28 days since prior radiotherapy and recovered

• At least 28 days since prior flutamide OR at least 42 days since prior bicalutamide or nilutamide

• Patients who have previously progressed despite antiandrogen withdrawal and who have started antiandrogens without reduction of serum PSA are eligible without requiring a 28- or 42-day washout interval after antiandrogen withdrawal

• No other prior systemic therapies, except androgen-deprivation therapy (i.e., orchiectomy or LHRH analogues only) or antiandrogens

• Surgery, brachytherapy, external-beam radiotherapy, and cryotherapy are not considered systemic therapies

• No other concurrent anticancer therapy

• No concurrent use of any of the following:

• Finasteride

• Other investigational 5a-reductase inhibitors

• Anabolic steroids

• Alpha-receptor blockers (e.g., indoramin, tamsulosin hydrochloride, prazosin, terazosin, alfuzosin hydrochloride, and doxazosin)

• Drugs with antiandrogenic properties (e.g., spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, and progestational agents)

• Products containing selenium = 75 mcg or vitamin E = 100 IU

• Saw palmetto

• EG6761

• No concurrent radiotherapy, including palliative radiotherapy for pain control

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• dutasteride
Oral

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Shah SK, Trump DL, Sartor O, Tan W, Wilding GE, Mohler JL. Phase II study of Dutasteride for recurrent prostate cancer during androgen deprivation therapy. J Urol. 2009 Feb;181(2):621-6. doi: 10.1016/j.juro.2008.10.014. Epub 2008 Dec 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to disease progression		Every 12 weeks	No
Primary	Toxicity		Daily while on Treatment	Yes
Secondary	Objective response (complete and partial) rate and serum prostate-specific antigen levels		Every 4 weeks	No
Secondary	Survival		Every 12 weeks	No