Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer (POINTER-PC)

University of Leeds0 sites480 target enrollmentSeptember 23, 2024

ConditionsProstate cancer Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Prostate cancer
Sponsor: University of Leeds
Enrollment: 480
Primary Endpoint: 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
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 23, 2024

End Date

November 30, 2030

Last Updated

last year

Study Type

Interventional

Sex

Male

Investigators

Sponsor

University of Leeds

Eligibility Criteria

Inclusion Criteria

•Age >=18 years, male
•Histological diagnosis of prostate adenocarcinoma
•Previous primary prostate cancer (PCa) treatment (radical prostatectomy [RP], primary/ post-operative radiotherapy [RT] or brachytherapy without previous pelvic nodal RT)
•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 randomisation
•World Health Organisation (WHO) performance status 0-
•Willing to be randomised to stereotactic body radiotherapy (SBRT), ENI-5 or ENI-
•Patients must be able to provide study-specific written informed consent
•Prepared to participate in follow-up by telephone or in-person

Exclusion Criteria

•Previous pelvic nodal radiotherapy
•Contraindications to SBRT or ENI (e.g. inflammatory bowel disease)
•Contraindications to ADT
•Local recurrence in the prostate gland
•Para-aortic nodal metastases (above the aortic bifurcation)
•Meso-rectal nodal metastases
•Bone or visceral metastases
•Severe late toxicity relating to primary/post-operative RT
•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)
•Castrate-resistant disease

Outcomes

Primary Outcomes

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 Outcomes

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.