A comparison of pelvic extended nodal irradiation and stereotactic body radiotherapy for patients with recurrent prostate cancer

Phase 3

• Conditions: Prostate cancer; Cancer

• Registration Number: ISRCTN11089334
• Lead Sponsor: University of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-09-23
• Last Update Posted: 30 September 2024
• Study Completion: 2030-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 480

Inclusion Criteria

1. Age >=18 years, male2. Histological diagnosis of prostate adenocarcinoma3. Previous primary prostate cancer (PCa) treatment (radical prostatectomy [RP], primary/ post-operative radiotherapy [RT] or brachytherapy without previous pelvic nodal RT)4. Maximum of three PET-CT defined macroscopically-involved pelvic lymph nodes (upper limit of the pelvis is defined as the aortic bifurcation) within 6 months prior to randomisation5. World Health Organisation (WHO) performance status 0-26. Willing to be randomised to stereotactic body radiotherapy (SBRT), ENI-5 or ENI-207. Patients must be able to provide study-specific written informed consent8. Prepared to participate in follow-up by telephone or in-person

Exclusion Criteria

1. Previous pelvic nodal radiotherapy2. Contraindications to SBRT or ENI (e.g. inflammatory bowel disease)3. Contraindications to ADT4. Local recurrence in the prostate gland5. Para-aortic nodal metastases (above the aortic bifurcation)6. Meso-rectal nodal metastases7. Bone or visceral metastases8. Severe late toxicity relating to primary/post-operative RT9. Other active malignancy (except non-melanoma skin cancer or other malignancy with a documented disease-free survival for a minimum of 3 years before randomisation)10. Castrate-resistant disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metastatic free survival (defined as time from randomisation to progression of the treated node(s), new nodal, bone or visceral metastatic disease, or death due to PCa) measured using patient records

Secondary Outcome Measures

Name	Time	Method
PROM-assessed late bowel toxicity at 3 years, measured using the Expanded Prostate Cancer Index Composite 26-item questionnaire (EPIC-26) bowel function sub-domain.