Comparing two types of radiotherapy for high-risk localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to compare the safety and efficacy of stereotactic body radiotherapy (SBRT) delivered to the prostate alone versus SBRT delivered to both the prostate and surrounding lymph nodes in men with high-risk localized prostate cancer. A total of 1128 participants will be enrolled, with half receiving treatment targeting only the prostate and the other half receiving treatment that includes the lymph nodes. The study will monitor participants for at least three and a half years to evaluate side effects and the effectiveness of each treatment in preventing cancer recurrence. The treatment will be conducted at NHS radiotherapy centers experienced in SBRT.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥ 18 years at randomisation
2. Histopathological confirmation of prostate adenocarcinoma with Gleason/ISUP grade group scoring within twelve months of randomisation (unless otherwise discussed with the CI or co-Clinical Leads)
3. Patients planned for 12-36 months androgen deprivation therapy
4. High risk localised prostate cancer as defined by

   * Gleason 8-10 (grade groups 4 and 5) and/or
   * Stage T3a/b or T4 and/or
   * PSA \> 20ng/ml (or \>10 ng/ml for patients on 5-alpha reductase inhibitors)
5. Multi-parametric MRI of the pelvis- to include at least one functional MRI sequence in addition to T2W imaging within twelve months of randomisation
6. Radiological staging to exclude metastatic disease, prior to starting ADT, with one of the following: PSMA PET-CT, fluciclovine/choline PET-CT, whole-body MRI, bone scan, CT of chest, abdomen and pelvis (imaging method as per local practice/standard of care).
7. WHO performance status 0-2
8. Ability of research subject to give written informed consent

Exclusion Criteria:

1. N1 or M1 disease
2. PSA \>50ng/ml (or \>25ng/ml for patients on 5-alpha reductase inhibitors), unless PET-CT imaging has been performed to confirm N0M0 disease
3. Previous active treatment for prostate cancer
4. Patients where SBRT is contraindicated: prior pelvic radiotherapy, inflammatory bowel disease, significant lower urinary tract symptoms N.B. where patient has repeated imaging showing bowel in close apposition to target volumes that would make pelvic radiotherapy highly unlikely to be deliverable should be excluded.
5. Contraindications to fiducial marker insertion, where used- including clotting disorders, or patients at high risk when stopping anticoagulation or antiplatelet medications
6. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts and would make pelvic node planning more difficult.
7. Patients who have had chemotherapy within 6 weeks of the start of radiotherapy.
8. Life expectancy \< 5 years

Where it's running

• Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer Centre
  Cork, Ireland Recruiting
• St Lukes Radiation Oncology Network
  Dublin, Ireland Recruiting
• Mid Western Radiation Oncology Centre
  Limerick, Ireland Recruiting
• James Cook University Hospital
  Middlesbrough, South Tees, United Kingdom Recruiting
• Worcestershire Acute Hospitals Nhs Trust
  Worcester, Worcestershire, United Kingdom Recruiting
• Belfast City Hospital
  Belfast, United Kingdom Recruiting

Study contacts

• Study coordinator: PACE-NODES Trial Manager
• Email: pace-nodes-icrctsu@icr.ac.uk
• Phone: 02087224000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.