Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Adult	NCI	RPCI-I-34904 NCT00403000

Objectives

Primary

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

Secondary

1. Evaluate the serum prostate-specific antigen (PSA) level and objective radiographic response rate in patients treated with dutasteride.
2. Determine the survival of patients treated with dutasteride.
3. Determine the quality of life of patients treated with dutasteride.

Entry Criteria

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

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 5α-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

Patient Characteristics:

• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Time to disease progression
Toxicity

Objective response (complete and partial) rate and serum prostate-specific antigen levels
Survival

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.

Shah SK, Trump DL, Sartor O, et al.: Phase II study of Dutasteride for recurrent prostate cancer during androgen deprivation therapy. J Urol 181 (2): 621-6, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

James Mohler, MD, Principal investigator		Ph: 716-845-3389; 800-685-6825

Registry Information
Official Title		Phase II Study of Dutasteride in Prostate Cancer Recurrent During Androgen Deprivation Therapy
Trial Start Date		2004-12-28
Registered in ClinicalTrials.gov		NCT00403000
Date Submitted to PDQ		2006-10-12
Information Last Verified		2007-05-06
NCI Grant/Contract Number		CA16056

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