Prostate cancer (PCA) with high risk of metastasis. MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 68Ga-complex of Glu-NH-CO-NH-Lys-(Ahx)-HBED-CC
Product Code: Ga-68-PSMA-11
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 68Ga-complex of Glu-NH-CO-NH-Lys-(Ahx)-HBED-CC
Sponsors
Deutsches Krebsforschungszentrum (DKFZ), Stiftung des öffentlichen Rechts
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the ability of Ga-68-PSMA-11 PET/CT imaging to detect prostate cancer tissue within a. the prostate gland on level of quadrant (or octant if possible) and b. pelvic lymph node metastases on level of 8 defined sub-regions. 2. To assess the clinical safety of Ga-68-PSMA-11. ;Secondary Objective: 1.To assess the ability of Ga-68-PSMA-11 PET/CT imaging to detect bone metastases in comparison to 99mTc bone scintigraphy 2.To compare Ga-68-PSMA-11 uptake in primary tumors with Gleason score in surgical specimens from RP. 3.Determine the percentage of patients in which pre-operative Ga-68-PSMA-11 PET/CT imaging would result into a change in clinical management. 4.To evaluate the impact of pre-operative Ga-68-PSMA-11 PET/CT imaging on target volume definition for radiotherapy. 5.Exploratory analysis of molecular and clinical biomarkers (CTC, RNA, DNA, proteins) in blood, serum and plasma. ;Primary end point(s): Primary endpoint is the detection of PET signals in prostate gland (on level of quadrant or octant if possible) and lymph nodes of the pelvis (on level of 8 defined subregions) after Ga-68-PSMA-11 injection. Another primary endpoint is occurrence of side effects. ;Timepoint(s) of evaluation of this end point: At Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include detection of bone metastasis, standard uptake values (SUV) of PET signals in prostate gland and lymph nodes of the pelvis, detection of PET signals outside the pelvis, and change of clinical therapy management. Moreover the impact of PSMA imaging on target volume definition in radiotherapy will be studied.;Timepoint(s) of evaluation of this end point: End of trial | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactDr Volker Meyer
ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H.
Outcome results
None listed