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

NCT00403000 | Completed Phase 2 DMC

• 2 other identifiers: CDR0000514492RPCI-I-34904
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer

Outcome Measures

Primary Outcomes (2)

• Time to disease progression

  Every 12 weeks

• Toxicity

  Daily while on Treatment

Secondary Outcomes (2)

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

  Every 4 weeks

• Survival

  Every 12 weeks

Interventions

dutasteride DRUG

Oral

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Related 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.

  PMID: 19091347 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• James L. Mohler, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 23, 2006
• Study Start: December 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: April 1, 2013
• Last Updated: May 1, 2013

Record last verified: 2013-04

Locations

US (1)