Prostate CancerPhase 3NCT04102553
F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence
A Phase 3 study testing F-18-PSMA-1007 and F-18-Fluorocholine in people with Prostate Cancer and Prostate Cancer Recurrent, run by ABX advanced biochemical compounds GmbH at 6 sites in France.
Trial summary
This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Recurrent
- What is being tested?
- F-18-PSMA-1007 and F-18-Fluorocholine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesFrance
- Study dates
- 6 Mar 2019to 19 Mar 2021
- Phase
- Phase 3
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male with original diagnosis of prostate carcinoma with prior definitive therapy
- suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after prostatectomy)
- life expectancy of 6 months or more as judged by the investigator
- willing and able to undergo all study procedures
- informed consent in writing (dated and signed)
Who cannot join
- age: less than18 years
- contraindications for F-18-Fluorocholine
- contraindications for any of the ingredients of F-18-PSMA-1007
- close affiliation with the investigational site; e.g. first-degree relative of the investigator
- at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
- having been previously enrolled in this clinical trial
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- mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
- being clinically unstable or requiring emergency treatment
- being considered a vulnerable person
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Jean Perrin Clermont-Ferrand
Clermont-Ferrand
Centre Léon Bérard LUMEN
Lyon
Hôpitaux de Brabois (Vandoeuvre-les-Nancy)
Nancy
Hôpital Européen Georges-Pompidou
Paris
Hôpital Tenon
Paris
Hospices Civils de Lyon
Pierre-Bénite
About this study
Official title: Phase III Study of F-18-PSMA-1007 vs F-18-Fluorocholine PET to Compare the Detection Rate of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer
This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.
- Conditions
- Prostate Cancer, Prostate Cancer Recurrent
- Being tested
- F-18-PSMA-1007, F-18-Fluorocholine
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18-PSMA-1007Drug
Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.
F-18-FluorocholineDrug
Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.
| Study group | Role | What they receive |
|---|---|---|
| F-18-PSMA-1007 | Experimental | Patients will receive F-18-PSMA-1007 PET/CT first, followed by F-18-Fluorocholine PET/CT. Receives: Drug: F-18-PSMA-1007; Drug: F-18-Fluorocholine |
| F-18-Fluorocholine | Active comparator | Patients will receive F-18-Fluorocholine PET/CT first, followed by F-18-PSMA-1007 PET/CT. Receives: Drug: F-18-PSMA-1007; Drug: F-18-Fluorocholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine
Measured: Within 6 months after PET/CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start6 Mar 2019
- Primary completion30 Oct 2020
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- ABX advanced biochemical compounds GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102553
- Sponsor's protocol ID
- ABX-CT-301
- Status last verified
- Jun 2021
- First submitted
- 24 Sep 2019
- Last updated
- 29 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Olivier P, Giraudet AL, Skanjeti A, Merlin C, Weinmann P, Rudolph I, Hoepping A, Gauthe M. Phase III Study of 18F-PSMA-1007 Versus 18F-Fluorocholine PET/CT for Localization of Prostate Cancer Biochemical Recurrence: A Prospective, Randomized, Crossover Multicenter Study. J Nucl Med. 2023 Apr;64(4):579-585. doi: 10.2967/jnumed.122.264743. Epub 2022 Nov 23.
PubMed 36418170
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of F-18-PSMA-1007 vs F-18-Fluorocholine PET to Compare the Detection Rate of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT04102553
- Acronym / sponsor ID
- ABX-CT-301
- Conditions
- Prostate Cancer, Prostate Cancer Recurrent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ABX advanced biochemical compounds GmbHIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 25 Sep 2019 (actual)
- 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.
This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-18-PSMA-1007 | Experimental | Drug: F-18-PSMA-1007, Drug: F-18-FluorocholinePatients will receive F-18-PSMA-1007 PET/CT first, followed by F-18-Fluorocholine PET/CT. |
| F-18-Fluorocholine | Active comparator | Drug: F-18-PSMA-1007, Drug: F-18-FluorocholinePatients will receive F-18-Fluorocholine PET/CT first, followed by F-18-PSMA-1007 PET/CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male with original diagnosis of prostate carcinoma with prior definitive therapy
- suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after prostatectomy)
- life expectancy of 6 months or more as judged by the investigator
- willing and able to undergo all study procedures
- informed consent in writing (dated and signed)
Key exclusion criteria (9 listed)
- age: less than18 years
- contraindications for F-18-Fluorocholine
- contraindications for any of the ingredients of F-18-PSMA-1007
- close affiliation with the investigational site; e.g. first-degree relative of the investigator
- at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
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 |
|---|---|---|
| F-18-PSMA-1007Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order. | Drug | F-18-Fluorocholine, F-18-PSMA-1007 |
| F-18-FluorocholinePatients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order. | Drug | F-18-Fluorocholine, F-18-PSMA-1007 |
Primary outcome
To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine
Time frame: Within 6 months after PET/CT
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 29 Jun 2021.
- Derived from this study: PubMed 36418170Olivier P, Giraudet AL, Skanjeti A, Merlin C, Weinmann P, Rudolph I, Hoepping A, Gauthe M. Phase III Study of 18F-PSMA-1007 Versus 18F-Fluorocholine PET/CT for Localization of Prostate Cancer Biochemical Recurrence: A Prospective, Randomized, Crossover Multicenter Study. J Nucl Med. 2023 Apr;64(4):579-585. doi: 10.2967/jnumed.122.264743. Epub 2022 Nov 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing F-18-PSMA-1007 and F-18-Fluorocholine in people with Prostate Cancer and Prostate Cancer Recurrent, run by ABX advanced biochemical compounds GmbH at 6 sites in France.
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 5 inclusion and 9 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 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine (time frame: Within 6 months after PET/CT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04102553, which also lists 1 linked publication.
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 29 Jun 2021.