Clinical trial · Interventional
MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer
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
NCT00706966CI-TRIAL-00013497completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Diagnostic procedures, such as MRI and magnetic resonance spectroscopy imaging, may help in learning how well dutasteride works in patients with benign prostatic hypertrophy and low-risk prostate cancer. PURPOSE: This clinical trial is studying MRI and magnetic resonance spectroscopy imaging in patients receiving dutasteride for benign prostatic hypertrophy and low-risk prostate cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nonmalignant Neoplasm | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dutasteride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dutasteride
- description
- Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
- interventionNames
- Drug: dutasteride
Primary outcomes (1)
- measure
- Change in Extent of Cancer
- timeFrame
- 1 month, 6 months
- description
- Proportion of voxels consistent with prostate cancer as measured by magnetic resonance spectroscopy imaging (MRSI). MRSI spectra were examined and scored as healthy or cancerous. The change in cancerous volumes over time was evaluated. Because a significant decrease in citrate and polyamines on MRSI spectra was noted at 1 month compared with baseline, healthy tissue appeared to be more like cancer and thus created a false impression that the cancer had grown after 1 month. To reduce this bias, primary comparisons were made between the 1-month and 6-month scans.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion criteria: * 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 * Zubrod performance status 0-1 * Able to swallow and retain oral medications Exclusion Criteria: * Other prior or concurrent invasive cancer, other than localized basal cell or squamous cell carcinoma of the skin * 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 * Unstable serious co-morbidities including, but not limited to, myocardial infarction, coronary artery syndrome, cardiac arrhythmias, symptomatic congestive heart failure, or cerebrovascular accident * Major medical or psychiatric illness that, in the investigator's opinion, would preclude the completion of treatment and interfere with follow up * Known hypersensitivity to any 5α-reductase inhibitor or drug chemically related to the study drug * Prior radical surgery (prostatectomy) or cryosurgery for prostate cancer * Prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * Prior or concurrent cytotoxic chemotherapy for prostate cancer * 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) * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.