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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02342054 |
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Date of registration:
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12/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Single Fraction Real-time High-Dose-Rate Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer
SINFRA_PROST |
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Scientific title:
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Prospective Phase II Trial of Single Fraction Real-time High-Dose-Rate (19-HDR) Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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49 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02342054 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Spain
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Contacts
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Name:
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Alfonso Gomez-Iturriaga, MD, PhD |
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Address:
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Telephone:
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946006233 |
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Email:
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ALFONSO.GOMEZDEITURRIAGAPINA@osakidetza.net |
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Affiliation:
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Name:
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Alfonso Gomez-Iturriaga, MD PhD |
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Address:
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Telephone:
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+34946006000 |
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Email:
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alfonso.gomezdeiturriaga@osakidetza.net |
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Affiliation:
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Name:
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Alfonso Gomez-Iturriaga, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Universitario Cruces/Biocruces |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men older than 18 years old
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- Clinical stage T1c/T2a disease
- Low and Intermediate risk disease defined as either Gleason 6 or Gleason 7 and PSA <
20 ng/ml.
- Prostate volume < 60 cc as determined by ultrasound, CT or MRI
- Life expectancy of more than 10 years
- Willing to give informed consent to participate in this clinical trial
- Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
- Eastern Cooperative Oncology Group (ECOG) of 0 - 2.
- Give competent informed consent to participate in this trial.
Exclusion Criteria:
- Documented nodal or distant metastases
- Previous pelvic radiotherapy
- Previous trans-urethral resection of prostate, previous prostatectomy or HIFU
- Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors is
permitted
- Poor baseline urinary function defined as International Prostate Symptom Score (IPSS)
>19
- Contra-indication to radical prostate radiotherapy
- Significant medical co-morbidity rendering patient unsuitable for general anaesthetic
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Radiation: MRI-TRUS fusion guided Single Frac HDR
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Primary Outcome(s)
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Quality of Life measured by alidated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC
[Time Frame: 12 months]
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Safety measured by i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize
[Time Frame: 12 months]
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Secondary Outcome(s)
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Patient satisfaction measured with Likert scale question
[Time Frame: 24 months]
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Acute toxicity measured by urinary retention rate, International Prostate Symptom Score over time, rectal toxicity and genitourinary toxicity
[Time Frame: 24 months]
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Efficacy, measured by PSA
[Time Frame: 24 months]
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Secondary ID(s)
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SINFRA_PROST
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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