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Trial record 1 of 1 for:    NCT05022914
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PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE (PSICHE)

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ClinicalTrials.gov Identifier: NCT05022914
Recruitment Status : Recruiting
First Posted : August 26, 2021
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi

Study Description
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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.

Condition or disease
Prostate Cancer Biochemical Relapse Fo Malignant Neoplasm of Prostate Prostate Adenocarcinoma Prostate Cancer Recurrent

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prostate-Specific Membrane Antigen (PSMA) Guided Approach for bIoCHEmical Relapse After Prostatectomy- A Prospective Observational Study-PSICHE
Actual Study Start Date : January 19, 2021
Estimated Primary Completion Date : January 19, 2024
Estimated Study Completion Date : January 19, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
1
Patients affected by biochemical relapse after radical prostatectomy undergoing staging PSMA-PET/CT and baseline blood sample for miRNA panel assessment.


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 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 Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]
    Time between end of tailored treatment after 68Ga-PSMA PET/CT and death.

  2. Cause-specific survival [ Time Frame: 2 years ]
    Time between end of tailored treatment and death for prostate Cancer.

  3. Radiological Progression Free Survival [ Time Frame: 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.

  4. Quality of Life [ Time Frame: 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

  5. Quality of Life [ Time Frame: 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)-PR25

  6. Management Change [ Time Frame: 2 years ]
    Assess the proportion of management changes induced by positive PSMA PET/CT results.

  7. Association between PSMA PET/CT Detection Rate and specific miRNA panel [ Time Frame: 2 year ]
    Association between PSMA PET/CT Detection Rate and specific miRNA panel


Biospecimen Retention:   Samples With DNA
Panel of miRNA (miR-186, miR-26a, miR-374a, miR-410, miR-660)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate cancer male patient
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient affected by biochemical recurrence after radical prostatectomy.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05022914


Contacts
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Contact: Lorenzo Livi, Prof. +390557947264 lorenzo.livi@unifi.it

Locations
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Italy
AOU Careggi Radiation Oncology Unit Recruiting
Florence, Italy, 50134
Contact: Lorenzo Livi, Prof.    +390557947264    segr-radiotp@dfc.unifi.it   
Contact: Giulio Francolini    3938576664    Francolinigiulio@gmail.com   
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
Investigators
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Principal Investigator: Lorenzo Livi, Prof. Azienda Ospedaliero-Universitaria Careggi
More Information
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Publications of Results:

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Responsible Party: Lorenzo Livi, Full Professor, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT05022914    
Other Study ID Numbers: PSICHE
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi:
PSMA
68Ga-PSMA PET/CT
PET/CT
Biochemical Relapse
 micro-RNA
SBRT
Radiotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
 Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Disease Attributes
Pathologic Processes