Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer
Pilot Study Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to assess the detection rate of local relapse after radical prostatectomy with either PSMA or 64Cu-PET/CTs and whether the delineation of relapsed lesions using both methods can facilitate/change the therapeutic strategy of the radiation oncologist
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2020
CompletedFirst Submitted
Initial submission to the registry
July 15, 2020
CompletedFirst Posted
Study publicly available on registry
January 11, 2021
CompletedJanuary 11, 2021
January 1, 2021
3 years
July 15, 2020
January 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To calculate the detection rate of PSMA and Cu-PET/CT of relapses in patients undergoing radical prostatectomy and subsequent biochemical recurrence
Ratio between positive PSMA and Cu-PET/CT patients and the total of enrolled patients (positive MRI)
60 months
Interventions
This study aims at assessing the detection rate of both PSMA and Cu-PET/CT on tissue relapse, study whether this method is equivalent to mpMR
Eligibility Criteria
You may qualify if:
- Localized prostate adenocarcinoma (M0), any PSA value, any Gleason Score
- Previous radical surgery with subsequent undetectable PSA (\<0.2 ng/ml)
- Biochemical recurrence (two consecutive PSA values of at least 0.2 ng/ml)
- M0 to 18F-choline PET/TC
- Local relapse at mpMR
- Age\>18 years
- Performance Status 0-1 according to ECOG
You may not qualify if:
- Detectable PSA after surgery
- Secondary bone lesions from prostate cancer or M1
- Hormone therapy started before staging examinations
- Previous pelvic radiotherapy
- Crohn's disease or ulcerative colitis (active phase)
- Psychiatric diseases
- Contraindication to MRI (metal prostheses, pacemakers, claustrophobia, etc.)
- Presence of coxo-femoral implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Regina Elena National Cancer Institute
Rome, 00144, Italy
Related Publications (1)
Bottero M, Faiella A, Giannarelli D, Farneti A, D'Urso P, Bertini L, Landoni V, Vici P, Sanguineti G. A prospective study assessing the pattern of response of local disease at DCE-MRI after salvage radiotherapy for prostate cancer. Clin Transl Radiat Oncol. 2022 Apr 27;35:21-26. doi: 10.1016/j.ctro.2022.04.010. eCollection 2022 Jul.
PMID: 35516461DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 15, 2020
First Posted
January 11, 2021
Study Start
June 22, 2017
Primary Completion
June 9, 2020
Study Completion
June 9, 2020
Last Updated
January 11, 2021
Record last verified: 2021-01