Prostate Cancer RecurrentPhase 3PythonNCT04734184
A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer
A Phase 3 study testing DCFPyL in people with Prostate Cancer Recurrent, run by Curium PET France at 1 site in France.
Trial summary
PYTHON is designed to establish the efficacy and safety of 18F-DCFPyL in comparison with that of 18F-fluorocholine, in patients with first biochemical recurrence (BCR) after initial definitive therapy (prostatectomy, external beam radiotherapy or brachytherapy) for histopathologically confirmed prostate adenocarcinoma… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Recurrent
- What is being tested?
- DCFPyL
- Type of treatment
- Injection or infusion
- How many people
- 217 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2020to Feb 2022
- 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.
- Age min 18 years.
- Histopathological proven prostate adenocarcinoma per original diagnosis.
- First suspected recurrence of prostate cancer based on rising prostate-specific antigen (PSA) after initial curative therapy with radical prostatectomy of PSA ≥ 0.2 ng/mL confirmed by a subsequent PSA value of ≥0.2 ng/mL or with radiation therapy (external beam or brachytherapy) of PSA > 2 ng/mL above the nadir after therapy regardless of the serum concentration of the nadir.
- Able and willing to provide informed consent and comply with protocol requirements
- Patient who can undergo all study procedures per Investigator's point of view
- Patient with social insurance cover.
Who cannot join
- Patients displaying any of the following criteria will not be included:
- ECOG > 2
- History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection)
- History of adjuvant radiotherapy
- History of cryotherapy, high-intensity focused ultrasound (HIFU)
- Other active malignant tumour
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- Treatment with Androgen Deprivation Therapy (ADT) in the past 30 days or ongoing
- Treatment with colchicine in the past 8 days or ongoing
- Treatment with hematopoietic colony stimulating factors (CSF) in the past 5 days or ongoing
- Unable to lie supine for imaging
- Known allergy to investigational or reference products or to any excipients
- Unable to provide written consent (linguistic or psychological inability)
- Participation in another clinical study within one month prior to inclusion
- Uncooperative, in the Investigator's opinion.
- Subjects deprived of their freedom by administrative or legal decision or who are under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Title A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer
PYTHON is designed to establish the efficacy and safety of 18F-DCFPyL in comparison with that of 18F-fluorocholine, in patients with first biochemical recurrence (BCR) after initial definitive therapy (prostatectomy, external beam radiotherapy or brachytherapy) for histopathologically confirmed prostate adenocarcinoma per original diagnosis. PET/CT scans will be each interpreted by three independent masked experts who are not otherwise involved in the trial.
Read the detailed description
The primary objective is the per-patient detection rate of 18F-DCFPyL in comparison with 18F-Fluorocholine. Secondary objectives include the assessment of the impact on patient treatment management, the per-region detection rate, the sensitivity and specificity on a per-patient and per-region basis, the concordance rate between both tracers, and the safety. The study was initiated in July 2020, and the recruitment of the planned 217 patients has been completed in October 2020. The follow-up phase is ongoing. Typically, as part of the routine care practice, these patients receive appropriate treatment and follow-up. The investigating sites are therefore requested for the period of 7 months after the second tracer injection, to provide any results of subsequent biopsies, imaging studies, clinical findings, PSA measurements, and disease management, if performed in routine practice. Treatment decisions are locally made at the discretion of the referring physician based on all available clinical information, including the non-masked local reports of both PET/CT and any other imaging results. After completion of the study, a consensus will be obtained from a multidisciplinary independent board (truth panel), based on the surrogate standard of reference which will include all the above-mentioned available results. Assessments will be made on a per-region and per-patient basis. The truth panel will consist in 3 independent experts not otherwise involved in the trial. All above information will be sequentially presented to the truth panel experts. The order of presentation of 18F-FCH PET/CT and 18F-DCFPyl PET/CT results will be randomized. The truth panel will have to assess the impact of each PET/CT examination on disease restaging and change in treatment intent, by filling in a patient management questionnaire after review of each PET/CT examination report.
- Conditions
- Prostate Cancer Recurrent
- Being tested
- DCFPyL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCFPyLDiagnostic test
Single dose injection
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start7 Jul 2020
- Primary completionMay 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curium PET France
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734184
- Sponsor's protocol ID
- 2020-000121-37
- Acronym
- Python
- Status last verified
- Feb 2021
- First submitted
- 27 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer
- ClinicalTrials.gov ID
- NCT04734184
- Acronym / sponsor ID
- Python / 2020-000121-37
- Conditions
- Prostate Cancer Recurrent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Curium PET FranceIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 2 Feb 2021 (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.
PYTHON is designed to establish the efficacy and safety of 18F-DCFPyL in comparison with that of 18F-fluorocholine, in patients with first biochemical recurrence (BCR) after initial definitive therapy (prostatectomy, external beam radiotherapy or brachytherapy) for histopathologically confirmed prostate adenocarcinoma per original diagnosis. PET/CT scans will be each interpreted by three independent masked experts who are not otherwise involved in the trial.
Detailed description
The primary objective is the per-patient detection rate of 18F-DCFPyL in comparison with 18F-Fluorocholine. Secondary objectives include the assessment of the impact on patient treatment management, the per-region detection rate, the sensitivity and specificity on a per-patient and per-region basis, the concordance rate between both tracers, and the safety. The study was initiated in July 2020, and the recruitment of the planned 217 patients has been completed in October 2020. The follow-up phase is ongoing. Typically, as part of the routine care practice, these patients receive appropriate treatment and follow-up. The investigating sites are therefore requested for the period of 7 months after the second tracer injection, to provide any results of subsequent biopsies, imaging studies, clinical findings, PSA measurements, and disease management, if performed in routine practice. Treatment decisions are locally made at the discretion of the referring physician based on all available clinical information, including the non-masked local reports of both PET/CT and any other imaging results. After completion of the study, a consensus will be obtained from a multidisciplinary independent board (truth panel), based on the surrogate standard of reference which will include all the above-mentioned available results. Assessments will be made on a per-region and per-patient basis. The truth panel will consist in 3 independent experts not otherwise involved in the trial. All above information will be sequentially presented to the truth panel experts. The order of presentation of 18F-FCH PET/CT and 18F-DCFPyl PET/CT results will be randomized. The truth panel will have to assess the impact of each PET/CT examination on disease restaging and change in treatment intent, by filling in a patient management questionnaire after review of each PET/CT examination report.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male.
- Age min 18 years.
- Histopathological proven prostate adenocarcinoma per original diagnosis.
- First suspected recurrence of prostate cancer based on rising prostate-specific antigen (PSA) after initial curative therapy with radical prostatectomy of PSA ≥ 0.2 ng/mL confirmed by a subsequent PSA value of ≥0.2 ng/mL or with radiation therapy (external beam or brachytherapy) of PSA > 2 ng/mL above the nadir after therapy regardless of the serum concentration of the nadir.
- Able and willing to provide informed consent and comply with protocol requirements
Key exclusion criteria (15 listed)
- ECOG > 2
- History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection)
- History of adjuvant radiotherapy
- History of cryotherapy, high-intensity focused ultrasound (HIFU)
- Other active malignant tumour
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 |
|---|---|---|
| DCFPyLSingle dose injection | Diagnostic test | – |
Primary outcome
to compare per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT.
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DCFPyL in people with Prostate Cancer Recurrent, run by Curium PET France at 1 site 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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 2 Feb 2021. 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 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?
Results are not available in the source record.
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 per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT. (time frame: 10 weeks). 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 2 Feb 2021.