PEARLS - a trial of radiotherapy in newly-diagnosed patients with lymph node positive prostate cancer

Not Applicable

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

• Registration Number: ISRCTN36344989
• Lead Sponsor: Institute of Cancer Research

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36238579/ (added 04/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-09
• Last Update Posted: 18 June 2024
• Study Completion: 2032-12-06

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 893

Inclusion Criteria

1. Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old).
2. Any T stage, N1, M0; any T stage, N1, M1a (limited to para-aortic region); or any T stage, N0, M1a (limited to para-aortic region) on PSMA PET-CT imaging done at time of diagnostic staging (stage IV disease).
3. Age at least 18 years.
4. Patient on LHRH analogue therapy.
5. Adequate renal and bone marrow function.
6. WHO Performance status of 0-2.
7. Written informed consent.

Exclusion Criteria

1. Prior radiotherapy to the prostate or pelvis; prior bilateral orchiectomy; radical prostatectomy.
2. For those patients who have received docetaxel chemotherapy or are receiving androgen receptor targeted therapy, there should be no ongoing CTCAE grade 2 or greater GI toxicity relating to this systemic therapy.
3. Medical conditions (non-prostate cancer related) expected to limit life expectancy to < 5 years.
4. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts and would make pelvic node planning more difficult.
5. Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, intractable urinary symptoms, previous colorectal surgery.
6. Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin or small renal masses under surveillance), or if previous malignancy is expected to significantly compromise 5 year survival.
7. Any other contraindication to external beam radiotherapy to the para-aortic and/or pelvic region.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase II: Acute lower gastrointestinal (GI) toxicity at week 18 from the start of radiotherapy measured using Radiation Oncology/Toxicity grading (RTOG)<br>Phase III: Metastasis-free survival (MFS) defined as the time from randomisation to the first detection of distant metastasis on imaging or death from any cause, whichever occurs first, measured using patient records. Distant metastasis defined as extra-pelvic lymphadenopathy, bone and visceral metastases