EUCTR2010-021886-63-GBActive, not recruitingPhase 1
A trial of Prostate Radiotherapy in Conjunction with Carbogen and Nicotinamide (PROCON) - PROCO
East and North Hertfordshire NHS Trust0 sites50 target enrollmentStarted: June 25, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
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
- •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
- •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
Investigators
Similar Trials
Completed
Phase 2
A trial of prostate radiotherapy in conjunction with carbogen and nicotinamideMalignant neoplasm of prostateCancerProstate cancerISRCTN08912168East and North Hertfordshire Hospitals NHS Trust (UK)50
Recruiting
Phase 3
Prostate Radiotherapy In high risk and node positive disease comparing Moderate & Extreme hypofractionation.CTRI/2018/05/014054Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre
Active, not recruiting
Phase 1
Artificial Intelligence driven personalisation of radiotherapy and concomitant androgen deprivation therapy for prostate cancer patientsMedDRA version: 20.0Level: PTClassification code: 10060862Term: Prostate cancer Class: 100000004864Prostate cancerCTIS2024-510707-11-00inac-Pet Scan Opco Limited30
Recruiting
Phase 3
Stereotactic body radiation therapy on Prostate with or without Androgen deprivation therapy, a phase III randomized controlled trial (SPA Trial)2024-520093-34-00Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia310
Completed
Not Applicable
Phase I trial evaluating combined radiotherapy with Panitumumab (Vectibix®) in patients with muscle invasive transitional cell carcinoma of the bladder10004994Bladder carcinomabladder cancerNL-OMON34833Antoni van Leeuwenhoek Ziekenhuis31