Dose escalation to intraprostatic tumour nodules in localised prostate cancer

Phase 2

• Conditions: Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN04483921
• Lead Sponsor: Institute for Cancer Research (UK)

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36150450/ (added 29/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-17
• Last Update Posted: 10 October 2022
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 265

Inclusion Criteria

1. Age more than or equal to 18 years
2. Histologically confirmed adenocarcinoma of the prostate
3. National Collaborative Cancer Network+ (NCCN) risk groups intermediate or high risk localised prostate cancer
4. Normal blood count [haemoglobin (Hb) > 11g/dl, white blood cell (WBC) > 4000/mm³, platelets > 100,000/mm³]
5. World Health Organisation (WHO) performance status 0 or 1
6. Life expectancy of 10 years or more
7. Written informed consent
8. Patients must be prepared to attend follow-up
9. For template biopsy sub-study must be considered fit for general / spinal anaesthetic; Target Gender: Male ; Lower Age Limit 18 no age limit or unit specified

Exclusion Criteria

1. Prior radiotherapy to the prostate or pelvis
2. Bilateral hip replacement
3. Prior hormone therapy
4. Radical prostatectomy
5. Lymph Node Risk > 30%
6. National Collaborative Cancer Network+ (NCCN) Favourable Risk Group
7. Evidence of seminal vesicle invasion, nodal or metastatic disease
8. Any previous invasive cancer in the past 5 years, with the exception of non-melanoma skin cancer
9. Patients with medical contraindication to magnetic resonance imaging (MRI) scanning

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ate rectal toxicity; Timepoint(s): 12 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. Acute genitourinary (Gu) and gastrointestinal (GI) toxicity; Timepoint(s): 18 weeks<br> 2. Biochemical Recurrence; Timepoint(s): 24 months<br> 3. Late GU and GI toxicity; Timepoint(s): 12 months and 24 months<br> 4. Quality of Life Scores; Timepoint(s): 24 months<br>