Metastasis assessment with Gallium-68 PSMA and Nanoparticle Imaging.
- Conditions
- Detection of lymph node metastasis in prostate cancer.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-005016-15-NL
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
- Male, aged 18 years (or older, if required by local law)
- Prostate cancer present (Gleason = 7) and/or PSA = 15 and/or Clinical or radiological Stage T3
- Suspected lymph node involvement pre-prostatectomy
- Suitable for radical prostatectomy and pelvic lymph node dissection, as per institutional guidelines and not yet treated pre-prostatectomy
- Subject is willing to sign and date the study Informed Consent form
- Signed, written informed consent
- Subject is expected to remain available for 24 months of clinic visits
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
- Previous treatment for prostate cancer (surgery, radiotherapy, chemotherapy, hormone androgen deprivation therapy)
- Proven metastatic disease
- Patients who refuse prostatectomy or pelvic lymph node dissection
- Patients who refuse to join the trial or are unable to consent
- Patients not being considered for further therapy
- Contra-indication to MRI scanning, IV iron infusion, allergy to dextran or other injectable contrast media used in this trial
- Patients who cannot lie still for at least 30 minutes or comply with imaging
- Unequivocal evidence of disease outside the pelvis on conventional imaging
- Subject has medical conditions that would limit study participation (per physician discretion)
- Subject has hemochromatosis and liver disease
- Subject has known allergy against Fe-products or dextranes
- Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by the study investigators
- Subject has a limited life expectancy that would not allow completion of the 24 month visits
- Subject meets the exclusion criteria required by local law
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method