ISRCTN08912168
Completed
Phase 2
A trial of PROstate radiotherapy in CONjunction with carbogen and nicotinamide (PROCON)
East and North Hertfordshire Hospitals NHS Trust (UK)0 sites50 target enrollmentFebruary 6, 2012
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate cancer
- Sponsor
- East and North Hertfordshire Hospitals NHS Trust (UK)
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histological diagnosis of prostate adenocarcinoma of Gleason grade 3\+3 or higher
- •2\. Radical radiotherapy is considered to be appropriate treatment
- •3\. Any of: PSA \> 20ng/ml, Gleason grade \> 8, T3 disease on MRI
- •4\. Patients must have radiographically documented measurable disease on pelvic MRI scan within 3 months of trial entry
- •5\. Age over 18 with no upper age limit
- •6\. Before patient registration, written informed consent must be given according to GCP and local regulations.
- •7\. Male participants
- •8\. Lower Age Limit 18 years
Exclusion Criteria
- •1\. Metastatic disease (including pelvic lymph node metastases) on conventional imaging including pelvic MRI scan and isotope bone scan within 3 months of trial entry
- •2\. PSA\>50
- •3\. T4 disease on pelvic MRI scan within 3 months of trial entry
- •4\. Prior treatment for prostate cancer, either local or systemic (other than neoadjuvant androgen deprivation for a period of less than 3 months)
- •5\. Current active malignancy other than prostate cancer or nonmelanomatous skin cancer
- •6\. Previous radiotherapy to the pelvis
- •7\. Comorbid conditions such that the technique of external beam radiotherapy is inappropriate
- •8\. Contraindication to MRI (only applicable to patients that are being considered for entry into the imaging component of the study)
- •9\. Current treatment with an ACE inhibitor
- •10\. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and followup schedule; those conditions should be discussed with the patient before registration in the trial
Outcomes
Primary Outcomes
Not specified
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