A trial of prostate radiotherapy in conjunction with carbogen and nicotinamide

Phase 2

Completed

• Conditions: Malignant neoplasm of prostate; Cancer; Prostate cancer

• Registration Number: ISRCTN08912168
• Lead Sponsor: East and North Hertfordshire Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-06
• Study Completion: 2013-09-01
• Last Update Posted: 26 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSA progression-free survival measured at 5 years

Secondary Outcome Measures

Name	Time	Method
Short-term and long-term GU and GI toxicity following treatment