EUCTR2010-021886-63-GB
Active, not recruiting
Phase 1
A trial of Prostate Radiotherapy in Conjunction with Carbogen and Nicotinamide (PROCON) - PROCO
East and North Hertfordshire NHS Trust0 sites50 target enrollmentJune 25, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]
- Sponsor
- East and North Hertfordshire NHS Trust
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histological diagnosis of prostate adenocarcinoma of Gleason grade 3\+3 or higher
- •Radical radiotherapy is considered to be appropriate treatment
- •Any of: PSA \> 20ng/ml, Gleason grade \> 8, T3 disease on MRI
- •Patients must have radiographically documented measurable disease on pelvic MRI scan within 3 months of trial entry
- •Age over 18 with no upper age limit
- •Before patient registration, written informed consent must be given according to GCP and local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 0
Exclusion Criteria
- •Metastatic disease (including pelvic lymph node metastases) on conventional imaging including pelvic MRI scan and isotope bone scan within 3 months of trial entry
- •T4 disease on pelvic MRI scan within 3 months of trial entry
- •Prior treatment for prostate cancer, either local or systemic (other than neo\-adjuvant androgen deprivation for a period of less than 3 months)
- •Current active malignancy other than prostate cancer or non\-melanomatous skin cancer
- •Previous radiotherapy to the pelvis
- •Co\-morbid conditions such that the technique of external beam radiotherapy is inappropriate
- •Contraindication to MRI (only applicable to patients that are being considered for entry into the imaging component of the study)
- •Current treatment with an ACE inhibitor
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule; those conditions should be discussed with the patient before registration in the trial
Outcomes
Primary Outcomes
Not specified
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