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

Roswell Park Comprehensive Cancer Center logo

Roswell Park Comprehensive Cancer Center

Status and phase

Completed
Phase 2

Conditions

Prostate Cancer

Treatments

Drug: dutasteride

Study type

Interventional

Funder types

Other

Identifiers

NCT00403000
CDR0000514492
RPCI-I-34904

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

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 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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