A study in male patients with newly diagnosed prostate cancer to assess the accuracy of an imaging tracer at diagnosing prostate cancer, in comparison to standard prostate biopsy. In addition, the study will collect additional data on the tracers safety, look at the possible ability in the tracer detecting cancer spread to nearby bone and look at the tumour uptake of the tracer.
- Conditions
- Prostate cancer (PCA) with high risk of metastasis.MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Registration Number
- EUCTR2016-001815-19-DE
- Lead Sponsor
- Deutsches Krebsforschungszentrum (DKFZ), Stiftung des öffentlichen Rechts
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 173
1.Written informed consent.
2.Male = 18 years of age.
3.Histologically confirmed adenocarcinoma of the prostate.
4.High risk for metastasis, defined by either:
a.stadium cT3 according to TNM classification, or
b.Gleason Score >7, or
c.PSA >20 ng/mL.
5.Patient scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND) according to current guidelines 7-60 days after start of the study.
6.Consent to practise contraception until end of study (6 days after Ga-68-PSMA-11 injection).
7.Preoperative PCA staging performed according to guidelines, to include a mandatory 99mTc bone scintigraphy and an optional pelvic MRI or CT, not older than 56 days prior to inclusion, according to standard of care.
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 87
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 86
1.Known hypersensitivity to Ga-68-PSMA-11 or its components.
2.Presence of known lymph node metastases outside surgical field.
3.More than 5 bone metastases, as determined by 99mTc bone scintigraphy.
4.Previous prostate cancer therapy.
5.Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the respective radionuclide.
6.Any other investigational medicinal product within 30 days prior and 7 days after receiving study medication.
7.Evidence of neuroendocrine small cell carcinoma.
8.Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders).
9. Simultaneous participation in other clinical trials.
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