Dose escalation to intraprostatic tumour nodules in localised prostate cancer

Dose EscaLation to Intraprostatic tumour Nodules in localisEd prostATE cancer: A phase II study examining the toxicity and feasibility of a dose escalated boost to a magnetic resonance imaging identified tumour nodule or nodules in localised prostate cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN04483921

Enrollment

350

Registered

2011-08-17

Start date

2011-07-13

Completion date

Unknown

Last updated

2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: National Cancer Research Network

Interventions

Interventions as of 03/05/2017: 350 patients to be recruited and have MRI scans to diagnose intra-prostatic tumour nodules. Intra-prostatic tumour lesions will be treated with a radio

Follow Up Length: 60 month(s)

Study Entry : Registration only Original interventions: 100 patients to be recruited and have MRI scans to diagnose intra-prostatic tumour nodules. 50% of patients exp

Study Entry : Registration only

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Late rectal toxicity; Timepoint(s): 12 months	—

Secondary

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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026