PEARLS
Research type
Research Study
Full title
A phase II/III trial of primary radiotherapy for androgen sensitive prostate cancer patients with lymph nodes
IRAS ID
287775
Contact name
Alison Tree
Contact email
Sponsor organisation
The Institute of Cancer Research
ISRCTN Number
ISRCTN36344989
Duration of Study in the UK
11 years, 6 months, 0 days
Research summary
PEARLS aims to improve patient outcomes by treating patients whose cancer has spread to the lymph nodes with radiotherapy to an extended area than is currently used. The investigators think that by extending radiation to cover a wider area where recurrences can often occur may improve control of the cancer. There is currently no standard management for prostate cancer patients who present at diagnosis with cancer having spread to the lymph nodes in the abdomen. Previous studies have indicated that it is safe to treat the prostate and pelvic areas with radiotherapy. There have been no recent studies using modern radiotherapy technology to treat larger areas within the abdomen.
PEARLS will assess the differences in side effects for patients treated with standard or an extended radiotherapy area to make sure these are acceptable and if they are, we will include more patients in the study to see if the extended radiotherapy treatment helps to control the cancer better.
PEARLS will recruit 893 patients with lymph node positive disease. An interim review of safety in the first 150 patients will permit early stopping of the trial if toxicity associated with the extended radiotherapy area is unacceptable.
Patients will be randomised based on the extent of disease in their lymph nodes to either a standard area or an extended area including the lymph nodes in the abdomen. Radiotherapy will involve treatment over 20 fractions for all patients. Patients will be followed up at regular intervals.
Patients will be asked to complete quality of life questionnaires. In addition, patients may be asked to take part in optional sub-studies running within PEARLS, which will include donation of blood samples, stool samples and an additional PSMA PET-CT scan 6 months after the end of radiotherapy and recurrence.
REC name
London - Central Research Ethics Committee
REC reference
21/LO/0178
Date of REC Opinion
4 Mar 2021
REC opinion
Favourable Opinion