Prostate Radiotherapy with Oxygen Enhancement

Phase 1

• Conditions: Prostate Cancer; MedDRA version: 14.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-021886-63-GB
• Lead Sponsor: East and North Hertfordshire NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 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
•PSA>50
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified