Status:
UNKNOWN
Dose Escalation to Dominant Intraprostatic Lesions (DIL) With MRI-TRUS Fusion High Dose Rate (HDR) Prostate Brachytherapy
Lead Sponsor:
Alfonso Gomez-Iturriaga
Collaborating Sponsors:
Hospital de Cruces
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The Magnetic Resonance (MR) provides high resolution of soft tissue images allowing an appropriate assessment of the local extent of the disease. Recent studies have shown an increase in sensitivity a...
Detailed Description
Treatment: The patient's treatment will consist of combined Hypofractionated external beam (3750 cGray in 15 fractions) and MRI-TRUS fusion HDR brachytherapy boost (1 fraction of 1500 cGray. Brachyt...
Eligibility Criteria
Inclusion
- Men ≥18 years
- Histologically proven adenocarcinoma of the prostate
- Intermediate or high risk prostate cancer
- Intermediate risk prostate cancer patients must have:
- Clinical stage ≤ T2c, Gleason score = 7 and iPSA ≤ 20, or Gleason score ≤ 6 and iPSA \> 10 and ≤ 20. High risk patients may have Clinical stage T3 Gleason score 8-10 PSA \> 20 ng/ml
- A palpable nodule or a cluster of positive biopsies from a single region suggesting the presence of dominant nodule and with radiologic correlation by MRI.
- Estimated life expectancy of at least 10 years.
- ECOG performance status of 0 - 2.
- Signature of informed conseny
Exclusion
- Contraindications to interstitial prostate brachytherapy.
- If on coumadin therapy and NOT able to stop safely for 7 days.
- Does not have a localized high volume of intraprostatic disease and MRI contraindicated
- Unfit for general anesthetic
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01909388
Start Date
June 1 2013
End Date
July 1 2016
Last Update
July 26 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Cruces
Barakaldo, Bizkaia, Spain, 48903