Males 18 years of age or older with histologically-proven prostate adenocarcinoma and biochemical relapse with rising PSA level after initial treatment with radical curative intent, not yet on palliative systemic treatment and considered for further salvage therapy MedDRA version: 19.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code
Conditions
Interventions
Product Name: 68Ga-(HBED-CC)-PSMA
Product Code: 68Ga-PSMA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: no proposed INN
Current Sponsor code: 68Ga-(HBED-CC)-PSMA_IJB
Other descripti
Sponsors
Institut Jules Bordet
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: •Age = 18 years old. •Histologically-proven prostate adenocarcinoma. •Biochemical recurrence after initial treatment with radical curative intent based on PSA values 1: a) Following Radical Prostatectomy (RP) +/- Radiotherapy (RT): a serum PSA increase confirmed by a second PSA measurement higher than the first one with a value of 0.2 ng/mL or more within minimum of one week. b) Following primary RT: PSA value of 2 ng/ml above the nadir. c) A continued rise in PSA level despite treatment with curative intent. •Patients with negative, inconclusive or oligometastatic disease on the RIW and susceptible to be treated with curative radical intent (salvage treatment). RIW exams are accepted when performed within 1 month before PSMA-PET/CT (this includes WB-MRI, prostatic/pelvic MRI, and/or Bone Scintigraphy). •Patient treatment strategy based on routine diagnostic work-up needs to be recorded after discussion at the UTB and available before the PSMA-PET/CT. •ECOG performance status = 2. •Signed informed consent prior to any study related procedure. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: •Previous malignancy other than PCa (except basocellular or squamous cell skin cancer). •Patients previously treated with palliative chemotherapy or new hormonal therapies like Abiraterone/Enzalutamide. •PSA rise while on active treatment (LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen). A minimal time window of 1 month is required. •Medical castration with Testosterone < 50 ng/dl (1.7 nmol/L). •Previous treatment with isotopes (Radium, Samarium, Strontium, etc.) •All medical conditions that might interfere with the correct performance of imaging scans. •Known allergy/sensitivity to 68Ga or HBED-CC coupled substance, or any of the ingredient(s) or excipient(s) of the study medication(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prospectively evaluate the impact of 68Ga-PSMA-ligand PET-CT (PSMA-PET/CT) on the therapeutic management of patients with biological recurrent prostate cancer and negative, equivocal or oligometastatic disease after routine imaging diagnostic work-up (RIW). A treatment management decision will be recorded at the urologic tumor board (UTB) before and after the PSMA-PET/CT result. Rate of decision change will be calculated. No new prostate cancer therapy is allowed between the signature of the Informed Consent Form (ICF) and the PSMA-PET/CT. ;Secondary Objective: 1)To compare detection rates of PSMA-PET/CT and RIW. 2)To search for a predictor of a positive PET scan. 3)To assess diagnostic value of PSMA-PET/CT. 4)To assess PSA response after targeted treatment for oligometastatic disease. 5)To evaluate the delay to start of Androgen Deprivation Therapy (ADT) from the UTB decision. 6)To evaluate the time to PSA progression.;Primary end point(s): Changes in treatment management are defined either as: •Shift to a different therapeutic strategy (systemic treatment vs surgery vs radiotherapy vs high intensity focused ultrasound vs hormonotherapy vs watchful waiting). •Modification of the initial therapeutic strategy (eg. change of surgical approach or change of radiotherapy planning). •No change ;Timepoint(s) of evaluation of this end point: at the 2nd urologic tumor board (UTB) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Number of positive scans •PSMA only positive •RIW only positive •Positive in both 2.Detection rates will be correlated with: •PSA value at the time of imaging •PSA doubling time •Gleason score 3.Reference diagnosis : •Histology when available. •Normalisation of PSA level after ablative therapy. •Morphological and/or biochemical evolution when no target treatment is given. 4.A confirmed PSA response is defined as = 30% reduction of the blood level, compared to the baseline value, confirmed by a second PSA value 4 or more weeks later. PSA responses will be evaluated at 1 month after targeted radiotherapy (RT) or surgery and 3 and 6 months after the UTB decision. 5.ADT free survival: time from UTB to start of ADT treatment during the follow period of 6 months. 6.Time to prostate specific antigen (PSA) progression according to Prostate Cancer Clinical Trials Working Group criteria: •In case of decline from baseline: record time from UTB to first PSA increase that is =25% and = 2 ng/ml above the nadir OR that is =25% above the pretreatment PSA value and which is confirmed by a second value 3 or more weeks later. •In case of no decline from baseline: PSA increase that is =25% and = 2 ng/ml after 3 months if baseline PSA is =2 ng/ml. PSA increase that is =25% after 3 months if baseline PSA is < 2 ng/ml. ;Timepoint(s) of evaluation of this end point: after the 2nd urologic tumor board (UTB) | — |
Countries
Belgium
Contacts
Public ContactDepartement medecine nucleaire
Institut Jules Bordet
Outcome results
None listed