HYPo-fractionated Radiotherapy of Lymph Node Metastases guided by NanO-MRI in Prostate Cancer Patients: A Pilot Study (HYPNO-study)

Phase 2

Recruiting

• Conditions: prostate carcinoma; prostate cancer; 10038597; 10036958

• Registration Number: NL-OMON50988
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Biochemical recurrent prostate adenocarcinoma after radical prostatectomy.
- PSA level >= 0.2 ng/ml
- No macroscopic disease on PSMA-PET/CT
- No local recurrence on MRI.
- <= 4 foci harbouring regional lymph node metastases (up to 6 nodes in total)
on nano-MRI (below aortic bifurcation).

Exclusion Criteria

- If any of the abovementioned does not apply.
- Concurrent or previous androgen deprivation therapy.
- Previous pelvic radiotherapy.
- Active inflammatory bowel disease (Crohn*s disease or ulcerative colitis).
- Contraindication for MR-imaging according to local Radiology protocol or
unable to undergo MR-linac treatment (e.g. due to claustrophobia or body
circumference).
- Ferro-magnetic objects in the pelvis or hip causing disturbing susceptibility
artifacts (at the discretions of the radiologist).
- Inability to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints of the study are 1-year PSA-relapse free survival as<br /><br>parameter for disease control and technical feasibility. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include acute and late treatment related toxicity and<br /><br>radiologic response.</p><br>