MRI-guided irradiation of prostate cancer lymph node metastases identified by nano-MRI.

Phase 1

• Conditions: men with biochemical recurrent prostate cancer after radical prostatectomy with = 4 foci harbouring regional lymph node metastases (up to 6 lymph nodes in total) on nano-MRI.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-003779-32-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-10
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- If any of the inclusion criteria 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.
- Contraindications to Ferrotran as stated in the SPC (including no consent to practice contraception until end of study in case of female partners of childbearing potential).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified