Dose Escalation to Dominant Intraprostatic Lesions (DIL) With MRI-TRUS Fusion High Dose Rate (HDR) Prostate Brachytherapy

NCT01909388 | Unknown Phase 2 DMC

• 1 other identifier: BRAPROST
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 and specificity for the detection of Dominant intraprostatic lesions when using multiparametric MRI as a diagnostic tool in the staging of the disease. Among the various irradiation techniques currently available for prostate cancer, Brachytherapy is the superior in terms of dose conformation; this conformation allows greater dose escalation, adjusting the isodoses to the prostate with exquisite accuracy, keeping healthy adjacent organs, such as the urethra and rectum, in a tolerable dose range Brachytherapy companies have recently developed software allowing for TRUS-MR image fusion. The purpose of this study is to demonstrate the feasibility of the delivery of a higher than prescription dose to the dominant intra-prostatic nodule as defined on multiparametric MRI. Dose to prostate, and adjacent structure will remain the same as the current treatment practice. Timing and the delivery of brachytherapy will not change from our current practice

Conditions

Prostate Cancer

Keywords

Cancer; Prostate Cancer; Brachytherapy; Dose escalation; High Dose Rate; MRI-TRUS fusion; Detection of DILs by MRI

Outcome Measures

Primary Outcomes (1)

• Feasibility of delivery higher than prescription doses (at least 125% of the dose)using inverse planned MRI-TRUS fusion high dose rate (HDR) brachytherapy.

  Use the multiparametric MRI to identify dominant intraprostatic lesions (DIL) and deliver higher doses to these lesions with real time HDR brachytherapy. The procedure will be considered feasible if DIL is covered by the 125% of prescription dose while respecting tolerance doses of adjacent normal organs

  12 months

Secondary Outcomes (2)

• Acute toxicity and tolerability compared to the historic cohort of patients treated with standard HDR brachytherapy

  24 months

• Efficacy assessed by PSA, Multiparametric MRI and prostate biopsy

  30 months

Study Arms (1)

MRI-TRUS fusion guided real time HDR

EXPERIMENTAL

Patients treated with dose escalation to Dominant Intraprostatic Lesions

Radiation: MRI-TRUS fusion guided real time HDR

Interventions

MRI-TRUS fusion guided real time HDR RADIATION

Also known as: Dose escalation to 125% of prescription dose, Planning software Oncentra Prostate for Nucletron

MRI-TRUS fusion guided real time HDR

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alfonso Gomez-Iturriaga: lead
• Hospital de Cruces: collaborator

Study Sites (1)

Hospital Universitario Cruces

Barakaldo, Bizkaia, 48903, Spain

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Alfonso Gomez-Iturriaga, MD

  Hospital de Cruces

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfonso Gomez-Iturriaga, MD, PhD

CONTACT

946006233; ALFONSO.GOMEZDEITURRIAGAPINA@osakidetza.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff physician department of Radiation Oncology

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 26, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2016
• Last Updated: July 26, 2013

Record last verified: 2013-07

Locations

ES (1)