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68Ga-PSMA HBED-PET/CT in the Evaluation of the Biochemical Relapse in Patients With a History of Prostate Cancer Radically Treated (GaPSMA)

Primary Purpose

68Ga-PSMA HBED-PET/CT, Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
68Ga- PSMA
Sponsored by
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for 68Ga-PSMA HBED-PET/CT focused on measuring 68Ga-PSMA, HBED-PET/CT, biochemical relapse, prostate cancer, radically treated

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed prostate cancer
  2. Male, aged >18 years.
  3. Radical treatment for prostate cancer (radiotherapy or surgery)
  4. 18F-FMC PET/CT negative or doubtful
  5. Negativity of all the other traditional morphological and functional imaging (transrectal ultrasound, bone scan, CT/MRI)
  6. Patients with PSA progression defined as PSA ≥ 1,0 ng/mL and/or PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
  7. Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
  8. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  1. No hormonotherapy in the last 6 months
  2. No radiotherapy in the last 6 months.
  3. Patients with PSA < 1.0 ng/ml
  4. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
  5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
  6. Medical or psychological conditions that would not permit the subject to complete to sign informed consent

Sites / Locations

  • Irst Irccs

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga- PSMA PET/CT

Arm Description

100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT

Outcomes

Primary Outcome Measures

the ratio between the number of 68Ga-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging
the ratio between the number of 68Ga-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging

Secondary Outcome Measures

Sensitivity for different PSA values (ranges)
Sensitivity of 68Ga- PSMA PET/CT for different PSA values (ranges)
Sensitivity for different lesion sites
Sensitivity of 68Ga- PSMA PET/CT for different lesion sites
PSA decrease: the receiver operating characteristic (ROC) curves generated by plotting sensitivity versus 1-specificity. Youden's index will be used for determining cut-off value between pos and neg 68Ga-PSMA PET/CT findings
for patients that will start an anticancer treatment: evaluate the predictive role of 68Ga- PSMA PET/CT on early response to therapy (hormonotherapy, abiraterone, enzalutamide) taking PSA decrease as a reference.
Evaluation of the concordance between 68Ga- PSMA PET/CT and PET/CT or the others standard methods, performed by the Cohen's kappa coefficient.
for patient without any treatment: evaluate the concordance between 68Ga- PSMA PET/CT and other standard methods and eventually optional biopsy
number of treated patients experiencing grade 1 to 4 adverse events
number of treated patients undergoing grade 1 to 4 adverse events evaluated according to CTCAE v.4.0
percentage of treated patients experiencing grade 1 to 4 adverse events
percentage of treated patients experiencing grade 1 to 4 adverse events

Full Information

First Posted
April 11, 2016
Last Updated
May 31, 2023
Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
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1. Study Identification

Unique Protocol Identification Number
NCT02920229
Brief Title
68Ga-PSMA HBED-PET/CT in the Evaluation of the Biochemical Relapse in Patients With a History of Prostate Cancer Radically Treated
Acronym
GaPSMA
Official Title
68Ga-PSMA, N,N'-Bis(2-hydroxybenzyl)Ethylenediamine-N,N'-Diacetic Acid (HBED)-PET/CT in the Evaluation of the Biochemical Relapse in Patients With a History of Prostate Cancer Radically Treated
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 9, 2020 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Single-center, prospective, diagnostic trial in radically treated patients with biochemical recurrence of prostate cancer. Patients with radically treated prostate cancer with biochemical relapse and negativity of all traditional morphological and functional imaging (transrectal ultrasound, bone scan, 18F-FMC PET/CT, CT/MRI) or doubtful imaging of 2-deoxy-2-[fluorine-18] (18F)-fluoromethylcholine (FMC) PET/CT will receive a Gallio-68 (68Ga)- Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET)/Computed Tomography (CT) scan.
Detailed Description
Single-center, prospective, diagnostic trial. The primary objective of this study is to evaluate the sensitivity of 68Ga-PSMA PET /CT defined as the ratio between the number of 68Ga-PSMA PET /CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging. The secondary objectives are: Sensitivity for different Prostatic Specific Antigen (PSA) values (ranges) Sensitivity for different lesion sites Treatment response assessment with a second PET False positives detection during Follow Up (FUP) (with other standard methods and eventually optional biopsy) for patient without any treatment safety 67 evaluable patients will be injected with 100-200 megabecquerel (MBq) 68Ga-PSMA intravenously

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
68Ga-PSMA HBED-PET/CT, Prostate Cancer
Keywords
68Ga-PSMA, HBED-PET/CT, biochemical relapse, prostate cancer, radically treated

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga- PSMA PET/CT
Arm Type
Experimental
Arm Description
100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT
Intervention Type
Drug
Intervention Name(s)
68Ga- PSMA
Intervention Description
100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT
Primary Outcome Measure Information:
Title
the ratio between the number of 68Ga-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging
Description
the ratio between the number of 68Ga-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Sensitivity for different PSA values (ranges)
Description
Sensitivity of 68Ga- PSMA PET/CT for different PSA values (ranges)
Time Frame
up to 24 months
Title
Sensitivity for different lesion sites
Description
Sensitivity of 68Ga- PSMA PET/CT for different lesion sites
Time Frame
up to 24 months
Title
PSA decrease: the receiver operating characteristic (ROC) curves generated by plotting sensitivity versus 1-specificity. Youden's index will be used for determining cut-off value between pos and neg 68Ga-PSMA PET/CT findings
Description
for patients that will start an anticancer treatment: evaluate the predictive role of 68Ga- PSMA PET/CT on early response to therapy (hormonotherapy, abiraterone, enzalutamide) taking PSA decrease as a reference.
Time Frame
up to 24 months
Title
Evaluation of the concordance between 68Ga- PSMA PET/CT and PET/CT or the others standard methods, performed by the Cohen's kappa coefficient.
Description
for patient without any treatment: evaluate the concordance between 68Ga- PSMA PET/CT and other standard methods and eventually optional biopsy
Time Frame
up to 24 months
Title
number of treated patients experiencing grade 1 to 4 adverse events
Description
number of treated patients undergoing grade 1 to 4 adverse events evaluated according to CTCAE v.4.0
Time Frame
up to 24 months
Title
percentage of treated patients experiencing grade 1 to 4 adverse events
Description
percentage of treated patients experiencing grade 1 to 4 adverse events
Time Frame
up to 24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have histologically or cytologically confirmed prostate cancer Male, aged >18 years. Radical treatment for prostate cancer (radiotherapy or surgery) 18F-FMC PET/CT negative or doubtful Negativity of all the other traditional morphological and functional imaging (transrectal ultrasound, bone scan, CT/MRI) Patients with PSA progression defined as PSA ≥ 1,0 ng/mL and/or PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart. Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: No hormonotherapy in the last 6 months No radiotherapy in the last 6 months. Patients with PSA < 1.0 ng/ml Participation in another clinical trial with any investigational agents within 30 days prior to study screening. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent. Medical or psychological conditions that would not permit the subject to complete to sign informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federica Matteucci, MD
Organizational Affiliation
IRST IRCCS, Meldola (FC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irst Irccs
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided

Learn more about this trial

68Ga-PSMA HBED-PET/CT in the Evaluation of the Biochemical Relapse in Patients With a History of Prostate Cancer Radically Treated

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