Prospective Evaluation of 68Ga-PSMA PET-CT for Recurrence Detection of Prostate Cancer and Its Impact on Patient Management (ProsPERo)
|ClinicalTrials.gov Identifier: NCT02810886|
Recruitment Status : Withdrawn (Recent publications demonstrating the clinical interest in performing 68Ga-PSMA for recurrence detection of prostate cancer patients with biochemical relapse)
First Posted : June 23, 2016
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancers||Drug: 68Ga-(HBED-CC)-PSMA||Phase 2|
68Ga-PSMA-ligand PET-CT is a recently developed molecular imaging technique. It is based on the prostate specific membrane antigen (PSMA), a transmembrane protein with a large extracellular domain which is over-expressed on prostate cancer cells surface. Initial experiments used a ligand to the extracellular epitope of PSMA and labelled it with the isotope 68Ga, a positron emitter (68Ga-PSMA-HBED-CC) 5.
Recently published data based on more than 300 patients show recurrence detection rates and tumour to background ratios higher than choline PET-CT, even at low Prostate Specific Antigen (PSA) levels (sensitivity of 70% in PSA<2ng/ml) 6,7. False-positive PSMA findings are not yet reported.
The therapeutic management of biochemical recurrence in prostate cancer depends on the localisation and the extent of the recurrent disease.
In this study, the hypothesis is that 68Ga-PSMA-ligand PET-CT, through its high diagnostic accuracy has a significant impact on the therapeutic management of patients with biochemical recurrence.
To prospectively evaluate the impact of 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.
The 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.
- To compare detection rates of PSMA PET/CT and Routine Imaging Workup
- To search for a predictor of a positive PET scan
- To assess diagnostic value of PSMA-PET/CT
- To assess PSA response after targeted treatment for oligometastatic disease.
- To evaluate the delay to start of Androgen Deprivation Therapy (ADT) from the UTB decision.
- To evaluate the time to PSA progression.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of 68Ga-PSMA-ligand PET-CT for Recurrence Detection of Prostate Cancer and Its Impact on Patient Management|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||January 20, 2017|
|Actual Study Completion Date :||January 20, 2017|
Experimental: Single, arm exploratory
Patients will undergo a 68Ga-PSMA PET/CT within 1 month after routine imaging diagnostic work-up.
68Ga-PSMA-ligand intravenous administration duration is around one minute. Once the patient is injected, the tracer needs 60 minutes to be evenly distributed through the body. PET/CT images will then be performed.
- Changes in treatment management are defined as: • Shift to a different therapeutic strategy • Modification of the initial therapeutic strategy • No changes [ Time Frame: 2 months ]
- Number of positive scans [ Time Frame: 2 months ]
- PSMA only positive
- Routine Imaging only positive
- Positive in both
- Correlation of positivity with: [ Time Frame: 2 months ]
- PSA value at the time of imaging
- PSA doubling time
- Gleason score
- Reference diagnosis [ Time Frame: 6 months ]
- Histology when available.
- Normalisation of PSA level after ablative therapy.
- Morphological and/or biochemical evolution when no target treatment is given.
- 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 for up to 6 months [ Time Frame: 6 months ]
- Androgen Deprivation Therapy (ADT) free survival: time from final Urologic Tumour Board treatment decision to start of ADT treatment during the follow up period of 6 months [ Time Frame: 6 months ]
- Time to prostate specific antigen (PSA) progression according to Prostate Cancer Clinical Trials Working Group criteria [ Time Frame: 3 months ]
- In case of decline from baseline: record time from final Urulogic Tumor Board treatment decision 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810886
|Study Chair:||Carlos Artigas, MD||Jules Bordet Institute|