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A Pilot Study of MRI and Spectroscopy Imaging Changes With 6-months of Dutasteride in Patients With Symptomatic Benign Prostatic Hypertrophy and Low-risk Prostate Cancer on Watchful Waiting or Requiring Neoadjuvant Androgen Suppression Prior to Prostate Brachytherapy


N/A
N/A
N/A
Open (Enrolling)
Male
Nonmalignant Neoplasm, Prostate Cancer

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Trial Information

A Pilot Study of MRI and Spectroscopy Imaging Changes With 6-months of Dutasteride in Patients With Symptomatic Benign Prostatic Hypertrophy and Low-risk Prostate Cancer on Watchful Waiting or Requiring Neoadjuvant Androgen Suppression Prior to Prostate Brachytherapy


OBJECTIVES:

Primary

- To determine whether there is a decrease in the extent of prostate cancer as measured
by endorectal MRI and magnetic resonance spectroscopy imaging in patients with
symptomatic benign prostatic hypertrophy and low-risk prostate cancer treated with
dutasteride for 6 months.

Secondary

- To monitor the effects of dutasteride on serum testosterone, dihydrotestosterone, and
free and total prostate-specific antigen (PSA).

- To monitor the effects of dutasteride on symptom and quality-of-life indices.

OUTLINE: Patients receive oral dutasteride once daily for 6 months.

Patients undergo endorectal MRI and magnetic resonance spectroscopy imaging at baseline and
at 1, 3, and 6 months.

Patients complete quality-of-life questionnaires using the International Index of Erectile
Function Questionnaire, American Urological Association Symptom Index, Functional
Alterations due to Changes in Elimination, and Spitzer Quality-of-Life Index at baseline and
at 1, 3, and 6 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Clinical stage T1b, T1c, or T2a disease

- Gleason score ≤ 6

- Maximal prostate-specific antigen (PSA) < 10 ng/mL

- Demonstrates intra-prostatic metabolite abnormalities, consistent with adenocarcinoma
of the prostate (i.e., ≥ 3 voxels with magnetic resonance spectroscopy imaging [MRSI]
scores 4-5) by baseline MRI and MRSI

- Has symptomatic benign prostatic hypertrophy and is currently undergoing watchful
waiting OR opting to undergo permanent seed implant (i.e., brachytherapy), but
requires neoadjuvant androgen suppression for prostate shrinkage

- No regional lymph node involvement

- No evidence of distant metastases

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Able to swallow and retain oral medications

- No other prior or concurrent invasive cancer, other than localized basal cell or
squamous cell carcinoma of the skin

- No contraindications to MRI/MRSI, including any of the following:

- Prostate biopsy (within the past 8 weeks) and any continued post-biopsy bleeding

- Rectal bleeding

- Anal fissures

- Rectal surgery (end-to-end anastomosis)

- Inflammatory bowel disease

- Prior radical prostatectomy

- Hip replacement

- Certain types of penile implants

- Vascular clips

- Known anaphylactic reaction to latex compounds

- Anticoagulant drugs

- Severe claustrophobia

- Cardiac pacemaker

- Metal in eye

- Any other metallic or foreign object in the body

- No unstable serious co-morbidities including, but not limited to, myocardial
infarction, coronary artery syndrome, cardiac arrhythmias, symptomatic congestive
heart failure, or cerebrovascular accident

- No major medical or psychiatric illness that, in the investigator's opinion, would
preclude the completion of treatment and interfere with follow up

- No known hypersensitivity to any 5α-reductase inhibitor or drug chemically related to
the study drug

PRIOR CONCURRENT THERAPY:

- See Patient Characteristics

- No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer

- No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

- No prior or concurrent cytotoxic chemotherapy for prostate cancer

- No prior hormonal therapy, such as luteinizing hormone-releasing hormone agonists
(e.g., goserelin or leuprolide acetate), antiandrogens (e.g., flutamide or
bicalutamide), or estrogens (e.g., diethylstilbestrol)

- No prior or concurrent finasteride, dutasteride, other drugs with known
antiandrogenic properties (e.g., spironolactone or progestational agents), or any
dietary or herbal supplement (e.g., selenium, vitamin E, saw palmetto, or PC-SPES)

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

Decrease of ≥ 50% in the proportion of voxels consistent with prostate cancer as measured by magnetic resonance spectroscopy imaging at baseline and at 6 months

Safety Issue:

No

Principal Investigator

Mack Roach, MD

Investigator Affiliation:

University of California, San Francisco

Authority:

Unspecified

Study ID:

CDR0000596822

NCT ID:

NCT00706966

Start Date:

June 2005

Completion Date:

Related Keywords:

  • Nonmalignant Neoplasm
  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • benign prostatic hyperplasia
  • Prostatic Hyperplasia
  • Neoplasms
  • Hypertrophy
  • Prostatic Neoplasms

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115