Prostate cancer Cancer
Conditions
Interventions
All participants will receive 12 months of hormone therapy, Androgen Deprivation Therapy (ADT), starting either on the first day of radiotherapy or up to one month before radiotherapy starts.
A compu
Sponsors
University of Leeds
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 06/11/2024: 1. Age >=18 years, male 2. Histological diagnosis of prostate adenocarcinoma 3. 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 (PSMA or Choline 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 5. World Health Organisation (WHO) performance status 0-2 6. Willing to be randomised to stereotactic body radiotherapy (SBRT), ENI-5 or ENI-20 7. Patients must be able to provide study-specific written informed consent 8. Prepared to participate in follow-up by telephone or in-person Previous participant inclusion criteria: 1. Age >=18 years, male 2. Histological diagnosis of prostate adenocarcinoma 3. 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 randomisation 5. World Health Organisation (WHO) performance status 0-2 6. Willing to be randomised to stereotactic body radiotherapy (SBRT), ENI-5 or ENI-20 7. Patients must be able to provide study-specific written informed consent 8. Prepared to participate in follow-up by telephone or in-person
Exclusion criteria
Exclusion criteria: 1. Previous pelvic nodal radiotherapy 2. Contraindications to SBRT or ENI (e.g. inflammatory bowel disease) 3. Contraindications to ADT 4. Local recurrence in the prostate gland 5. Para-aortic nodal metastases (above the aortic bifurcation) 6. Meso-rectal nodal metastases 7. Bone or visceral metastases 8. Severe late toxicity relating to primary/post-operative RT 9. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 06/11/2024: 1. 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 Prostate Cancer (PCa)) measured using patient records 2. 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. Previous primary outcome measure: Metastatic free survival (defined as the time from randomisation to progression of the treated node(s), new nodal, bone or visceral metastatic disease, or death due to Prostate Cancer (PCa)) measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/01/2026: 1. Overall survival (defined as the time from randomisation to death from any cause) 2. Biochemical progression-free survival (bPFS, defined as =2 ng/ml increase in PSA above the nadir value achieved after completion of RT) 3. Failure-free survival (defined as the time from randomisation to biochemical failure, the commencement of further anticancer therapy for PCa, further nodal, bone or visceral metastases or death from PCa) 4. Patterns of failure: Local, treated-node(s), other regional/ pelvic lymph node(s), para-aortic lymph node(s), other extra-pelvic lymph node(s), bone metastasis, visceral metastasis (liver, lung), other metastasis 5. Urinary and bowel toxicities, measured using the relevant EPIC-26 function and other sub-domains at baseline (pre-randomisation) and 2 weeks, 3 months, 6months, 12 months, 24 months and 36 months post-RT 6. Health-Related Quality of Life (HRQoL), measured using EORTC QLQ-C30 at baseline (pre-randomisation) and 2 weeks, 3 months, 6 months, 12 months, 24 months and 36 months post-RT 7. Clinician-reported toxicity at baseline, end of treatment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months post-RT and annually thereafter until 3 years post randomisation of the final participant and maximum acute (=3 months) and late (>3 months) bowel and urinary toxicity, measured using CTCAE v5.0 Previous secondary outcome measures as of 06/11/2024: 1. Overall survival (defined as the time from randomisation to death from any cause) 2. Biochemical progression-free survival (bPFS, defined as =2 ng/ml increase in PSA above the nadir value achieved after completion of RT) 3. Failure-free survival (defined as the time from randomisation to biochemical failure, the commencement of further anticancer therapy for PCa, further nodal, bone or visceral metastases or death from PCa) 4. Patterns of failure: Local, treated-node(s), other regional/ pelvic lymph | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactSamantha Noutch
Outcome results
None listed