Biochemical Relapse Fo Malignant Neoplasm of Prostate, Prostate Adenocarcinoma, Prostate Cancer, Prostate Cancer Recurrent
Conditions
Keywords
PSMA, 68Ga-PSMA PET/CT, PET/CT, Biochemical Relapse, micro-RNA, SBRT, Radiotherapy
Brief summary
This observational study was designed to evaluate progression free survival after PSMA-PET/CT based salvage approach for patients affected by biochemical relapse after radical prostatectomy.
Detailed description
This is a prospective observational multicenter study including patients treated with upfront radical prostatectomy +/- postoperative prostate bed radiotherapy, with histological result of Prostate adenocarcinoma, affected by biochemical relapse (defined as PSA\>/= 0.2 ng/ml) with a PSA at recurrence \</=1 ng/ml. Patients will be staged with centralized 68 Ga- PSMA PET/CT and treated with a pre-defined approach based on 68 Ga-PSMA PET/CT findings. The predefined approach will consist in the following flowchart: 1. In negative 68Ga-PSMA PET/CT or positive findings within prostate bed: Prostate bed RT 2. In 68Ga-PSMA PET/CT detecting pelvic nodal recurrence amenable with stereotactic body radiation therapy (SBRT) on all sites of disease: SBRT to all positive nodal disease. 3. In abdominal nodal or bone oligometastatic disease amenable with stereotactic body radiation therapy (SBRT) on all sites of disease: SBRT on all sites of disease 4. In abdominal nodal or bone metastatic disease (\>3 lesions or non-amenable with SBRT) and/or visceral disease: ADT+/-other systemic therapies available for metastatic hormone sensitive pCa at physician discretion.
Interventions
None listed
Sponsors
Azienda Ospedaliero-Universitaria Careggi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Age \>18 * Patient suitable for 68Ga-PSMA PET/CT re-staging according to clinical practice (Previous radical prostatectomy with histological result of Prostate adenocarcinoma +/- postoperative prostate bed radiotherapy (adjuvant or salvage setting), with a biochemical relapse defined as a PSA \> 0.2 and \<1
Exclusion criteria
* ADT administration within 6 months from study enrollment * Persistent elevation of PSA after RP measured within 16 weeks from surgery (\> 0.1 ng/ml)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 2 year | PFS is defined as time from end of salvage treatment performed at first relapse to documented biochemical progression or radiological progression (or both), death from any cause or censoring at date of last follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cause-specific survival | 2 years | Time between end of tailored treatment and death for prostate Cancer. |
| Radiological Progression Free Survival | 2 years | The occurrence of any new lesion detectable with PSMA. PET/CT and/or any other molecular/radiological exam, which will be performed in case of biochemical or clinical progression. |
| Overall Survival | 2 years | Time between end of tailored treatment after 68Ga-PSMA PET/CT and death. |
| Management Change | 2 years | Assess the proportion of management changes induced by positive PSMA PET/CT results. |
| Association between PSMA PET/CT Detection Rate and specific miRNA panel | 2 year | Association between PSMA PET/CT Detection Rate and specific miRNA panel |
| Quality of Life | 2 years | Record rate of patients with impaired quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 |
Countries
Italy
Contacts
Primary ContactLorenzo Livi, Prof.
Outcome results
None listed