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

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02920229
• Other study ID #: IRST185.02
• Secondary ID: 2015-003397-33
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: September 2023

Study information

• Verified date: May 2023
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: September 2023
• Est. primary completion date: October 9, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 68Ga-PSMA HBED-PET/CT
• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Italy	Irst Irccs	Meldola	FC

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensitivity for different PSA values (ranges)	Sensitivity of 68Ga- PSMA PET/CT for different PSA values (ranges)	up to 24 months
Secondary	Sensitivity for different lesion sites	Sensitivity of 68Ga- PSMA PET/CT for different lesion sites	up to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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