Status:
COMPLETED
Ga-68-PSMA-11 in High-risk Prostate Cancer
Lead Sponsor:
German Cancer Research Center
Collaborating Sponsors:
ABX CRO
Friedrich-Alexander-Universität Erlangen-Nürnberg
Conditions:
High-risk Prostate Cancer
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This will be an open-label, single-arm, rater-blinded, multicenter, diagnostic phase 1/2 study to assess safety and diagnostic performance of Ga-68-PSMA-11 positron emission tomography / computer tomo...
Eligibility Criteria
Inclusion
- Written informed consent.
- Male ≥ 18 years of age.
- Histologically confirmed adenocarcinoma of the prostate.
- High risk for metastasis, defined by either:
- stadium cT3 according to TNM (primary tumor, regional nodes, metastasis) Classification of Malignant Tumours (TNM), or
- Gleason Score \>7, or
- Prostate-Specific Antigen (PSA) \>20 ng/mL.
- Patient scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND) according to current guidelines 7 - 60 days after start of study.
- Consent to practise contraception until end of study (6 days after Ga-68-PSMA-11 injection).
- 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.
Exclusion
- Known hypersensitivity to Ga-68-PSMA-11 or its components.
- Presence of known lymph node metastases outside surgical field.
- More than 5 bone metastases, as determined by 99mTc bone scintigraphy.
- Previous prostate cancer therapy.
- Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the respective radionuclide.
- Any other investigational medicinal product within 30 days prior and 7 days after receiving study medication.
- Evidence of neuroendocrine small cell carcinoma.
- Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders).
- Simultaneous participation in other clinical trials
Key Trial Info
Start Date :
October 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2020
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT03362359
Start Date
October 9 2017
End Date
July 6 2020
Last Update
July 27 2020
Active Locations (8)
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1
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
2
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
3
Friedrich-Alexander-Universität Erlangen
Erlangen, Germany, 91054
4
Universität Duisburg-Essen
Essen, Germany, 45147