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

PACE-NODES. A Phase III Randomised Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT

Phase 3 Interventional Institute of Cancer Research, United Kingdom · NCT05613023

This study is testing whether targeting just the prostate or both the prostate and nearby lymph nodes with a specific type of radiotherapy is safer and more effective for men with high-risk localized prostate cancer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1128 (estimated)
Ages18 Years and up
SexMale
SponsorInstitute of Cancer Research, United Kingdom Academic / other
Drugs / interventionschemotherapy
Locations42 sites (Cork and 41 other locations)
Trial IDNCT05613023 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 18 and older with high-risk localized prostate cancer as defined by specific Gleason scores, staging, and PSA levels.

Not a fit: Patients with metastatic prostate cancer or those not meeting the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for men with high-risk localized prostate cancer, potentially reducing the chance of cancer recurrence.

How similar studies have performed: Other studies have shown promising results with SBRT approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Cork and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.