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.
Conditions
Interventions
Product Name: Ferumoxtran-10
Pharmaceutical Form: Infusion
INN or Proposed INN: Ferumoxtran-10 lyophilisate
Other descriptive name: SUPERPARAMAGNETIC IRON OXIDE NANOPARTICLES STABILISED WITH DEXTRAN A
Sponsors
Radboud University Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the technical feasibility and efficacy of MR-guided stereotactic body radiotherapy (SBRT) to nano-MRI detected regional lymph node metastases in patients with biochemical recurrent prostate cancer after radical prostatectomy.;Secondary Objective: - to determine the tolerability of the abovementioned treatment in terms of acute and late toxicity, both scored according to the Common Terminology Criteria for Adverse Events . - to determine the radiologic response of abovementioned treatment on repeated nano-MRI’s.;Primary end point(s): The main objective of this study is to determine the technical feasibility and efficacy of MRI guided lymph node SBRT in patients with biochemical recurrent prostate cancer after RP and small lymph node metastases on nano-MRI. - The study approach will be deemed technical feasible when in 90% of patients 1) the nano-MR detected lymph nodes can be objectified on the pre-radiotherapy planning MRI and daily MR-imaging, and 2) as a result can be treated by SBRT according to the set objectives and constraints without excessive > grade 2 treatment related toxicity (i.e. in > 5% of patients). - Efficacy will measured by the 1-year biochemical control, reflecting disease control. As no formal definition exists for a secondary biochemical relapse, in this study the 1-year biochemical control is defined as a PSA value 1 year after treatment that is < 0.2 ug/l higher than the value at baseline (in case of biochemical relapse confirmation after 6 weeks is needed);Timepoint(s) of evaluation of this end point: Technical feasibility: this will be determined before and during treatment. Efficacy: PSA-testing will take place at 3, 6, 9 and 12 (primary endpoint) months after treatment and afterwards according to standard of care. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - physician scored acute (until 90 days after treatment) and late toxicity measured by the Common Terminology Criteria for Adverse Events. - radiologic response of the treated lymph nodes on repeated nano-MRI at 3, 12 and 24 months after treatment will be determined and explorative analyses will be performed to see whether imaging biomarkers are correlated to biochemical outcome.;Timepoint(s) of evaluation of this end point: - Toxicity scoring will be performed at baseline, once during treatment, and 6 weeks after treatment, as well as 3, 6, 9, 12, 18, 24, 30 and 36 months after treatment and annually afterwards. The scoring will take place during regular follow-up visits. - repeated nano-MRI's will be performed at 3, 12 and 24 months after treatment. | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Radiation Oncology
Radboud University Medical Center
Outcome results
None listed