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A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer


- Participants will be seen by the study physician every four weeks and have a short
physical examination, blood tests and be asked to provide information about their
condition. Every three months they will undergo a bone scan. If the CT scan that was
obtained before the participant started the study shows evidence of cancer, they will
be asked to repeat this test every three months.

- Ketaconazole will be taken orally three times a day on an empty stomach.
Hydrocortisone will be taken orally in the morning and at night. Dutasteride will be
taken orally once a day.

- Participants may remain on study drug until there is evidence of disease progression.


Inclusion Criteria:



- Histologically documented evidence of prostate cancer (needle biopsy or
prostatectomy). In the abscence of histologically documented evidence of prostate
cancer, the diagnosis must be based on elevated serum PSA and metastatic lesions on
bone scan.

- Progressive HRPC defined as a PSA increase over baseline of >25% or 5ng/ml or new
lesions on bone/CT scan after conventional androgen deprivation and antiandrogen
withdrawal. Evidence of metastatic disease based on positive CT or bone scan is not
required.

- PSA of greater than or equal to 2ng/ml and serum total testosterone less than or
equal to 50ng/ml

- Prior chemotherapy is permitted if discontinued > 4 weeks prior to starting therapy

- Prior therapy with estrogens is permitted but must have been discontinued > 4 weeks
prior to registration

- ECOG Performance Status 0-2

- Adequate renal function, hepatic function, and bone marrow function as outlined in
protocol

- ECG showing a normal QT interval

Exclusion Criteria:

- Prior therapy with ketoconazole or corticosteroids for HRPC

- Major surgery or radiation therapy within 4 weeks

- Strontium-89 or samarium-153 therapy within 4 weeks

- Thromboembolism in past 6 months

- Patients who are taking drugs that may further prolong QT intervals and present a
known risk for Torsades de Pointes.

- Concomitant use of drugs known to be narrow therapeutic index CTP3A4

- Drugs that are sensitive CYP3A4 substrates

- Alcohol or drug dependence currently or in the last 6 months

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of high dose ketoconazole and hydrocortisone in combination with dutasteride (KHAD) in the treatment of hormone refractory prostate cancer.

Outcome Time Frame:

TBD

Safety Issue:

No

Principal Investigator

Steven Balk, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

04-414

NCT ID:

NCT00673127

Start Date:

February 2005

Completion Date:

December 2012

Related Keywords:

  • Prostate Cancer
  • hormone refractory
  • KHAD
  • ketoconazole
  • dutasteride
  • hydrocortisone
  • Prostatic Neoplasms

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Oregon Health and Science UniversityPortland, Oregon  97201
Sidney Kimmel Comprehensive Cancer Center at John Hopkins UniversityBaltimore, Maryland