68Ga-PSMA HBED-PET/CTGaPSMANCT02920229
68Ga-PSMA HBED-PET/CT in the Evaluation of the Biochemical Relapse in Patients With a History of Prostate Cancer Radically Treated
A study testing 68Ga- PSMA in people with 68Ga-PSMA HBED-PET/CT and Prostate Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- 68Ga-PSMA HBED-PET/CT, Prostate Cancer
- What is being tested?
- 68Ga- PSMA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,230 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2015to 9 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- 68Ga-PSMA HBED-PET/CT, Prostate Cancer
- Being tested
- 68Ga- PSMA
- Keywords
- 68Ga-PSMA, HBED-PET/CT, biochemical relapse, prostate cancer, radically treated
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga- PSMADrug
100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 68Ga- PSMA PET/CT | Experimental | 100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT Receives: Drug: 68Ga- PSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 months
Secondary outcomes (6)
Sensitivity for different PSA values (ranges)
Sensitivity of 68Ga- PSMA PET/CT for different PSA values (ranges)
Measured: up to 24 months
Sensitivity for different lesion sites
Sensitivity of 68Ga- PSMA PET/CT for different lesion sites
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startNov 2015
- Primary completion9 Oct 2020
- Study completion9 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 68Ga-PSMA HBED-PET/CTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federica Matteucci, MD, Principal investigator, IRST IRCCS, Meldola (FC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920229
- Sponsor's protocol ID
- IRST185.02
- Other IDs
- 2015-003397-33, 2015
- Acronym
- GaPSMA
- Status last verified
- Jan 2025
- First submitted
- 11 Apr 2016
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02920229
- Acronym / sponsor ID
- GaPSMA / IRST185.02
- Conditions
- 68Ga-PSMA HBED-PET/CT, Prostate Cancer
- Keywords
- 68Ga-PSMA, HBED-PET/CT, biochemical relapse, prostate cancer, radically treated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,230 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga- PSMA PET/CT | Experimental | Drug: 68Ga- PSMA100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga- PSMA100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT | Drug | 68Ga- PSMA PET/CT |
Primary outcome
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
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
6 secondary outcomes
Sensitivity for different PSA values (ranges)
Time frame: up to 24 months
Sensitivity for different lesion sites
Time frame: 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
Time frame: 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.
Time frame: up to 24 months
number of treated patients experiencing grade 1 to 4 adverse events
Time frame: up to 24 months
percentage of treated patients experiencing grade 1 to 4 adverse events
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Undecided. undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federica Matteucci, MD principal investigator
IRST IRCCS, Meldola (FC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga- PSMA in people with 68Ga-PSMA HBED-PET/CT and Prostate Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.