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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; 68Ga-PSMA HBED-PET/CT
• Intervention / Treatment: Drug: 68Ga- PSMA

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

• Study Type: Interventional
• Enrollment (Actual): 1230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • FC
    • Meldola, FC, Italy, 47014
      • Irst Irccs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga- PSMA PET/CT; 100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT	Drug: 68Ga- PSMA; 100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity for different PSA values (ranges)	Sensitivity of 68Ga- PSMA PET/CT for different PSA values (ranges)	up to 24 months
Sensitivity for different lesion sites	Sensitivity of 68Ga- PSMA PET/CT for different lesion sites	up to 24 months
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.	up to 24 months
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	up to 24 months
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	up to 24 months
percentage of treated patients experiencing grade 1 to 4 adverse events	percentage of treated patients experiencing grade 1 to 4 adverse events	up to 24 months

Collaborators and Investigators

• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
• Investigators: Principal Investigator: Federica Matteucci, MD, IRST IRCCS, Meldola (FC)

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): October 9, 2020
• Study Completion (Actual): October 9, 2020

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (Estimated): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: prostate cancer; 68Ga-PSMA; biochemical relapse; HBED-PET/CT; radically treated
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Prostatic Neoplasms; Recurrence; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: IRST185.02; 2015-003397-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: undecided