Prostate CancerPhase 2PICT-01NCT04009967
Biomarkers for Neoadjuvant Pembrolizumab in Non-Metastatic Prostate Cancer Positive by 18FDG-PET Scanning
A Phase 2 study testing Pembrolizumab in people with Prostate Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
Various approaches are currently being developed for prostate cancer immunotherapy. However, a major challenge facing the development of cancer immunotherapy is the identification of tumors that would best respond to this type of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2020to 30 Mar 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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≥ 18 years old
- Non-metastatic prostate cancer with histologically confirmed Gleason sum ≥8
- Eligible for radical prostatectomy with a delay of 6 to 9 weeks
- Intraprostatic maximum standardized uptake value (SUVmax) ≥4 at 18-FDG-PET/CT exam.
- Not be castrated or under androgen deprivation therapy
- Not have received prior neo adjuvant hormonotherapy.
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- Provided archival formalin-fixed, paraffin embedded tumor biopsy of the prostate tumor lesion not previously irradiated
- Performance status of Eastern Cooperative Oncology Group 0 to 1
- Adequate organ function
Who cannot join
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4 (Cytotoxic T-lymphocyte-Associated Protein 4), OX-40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
- Has received prior radiotherapy to the prostate or other organs within 2 weeks of start of study treatment.
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- Is participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
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- Other primary cancer within 3 years
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has a known history of Hepatitis B or known active Hepatitis C virus infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is expecting to father children within the projected duration of the study, starting with the screening visit through the date of prostatectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical and Translational Study of Neoadjuvant Pembrolizumab Before Radical Prostatectomy in Non-metastatic Gleason ≥8 Prostate Cancer Patients Positive by 18FDG-PET Scanning ( PICT-01)
Various approaches are currently being developed for prostate cancer immunotherapy. However, a major challenge facing the development of cancer immunotherapy is the identification of tumors that would best respond to this type of treatment. Different studies suggest that prostate cancer more likely to progress are more infiltrated by exhausted T cells expressing the cell surface protein PD1 (Programmed cell death 1). Therefore, there is a strong rationale for selecting patients at higher risk of progression for testing the efficacy of anti-PD1 therapy.
High glucose metabolism as detected by fludeoxyglucose F18 (FDG)-positron emission tomography (PET) (18FDG-PET) imagery is an innovative biological biomarker-based method to identify patients at higher risk of recurrence and early failure to hormonotherapy. Recent study demonstrated that high intra-prostatic 18-FDG-uptake was associated with higher Gleason grades. Therefore the one third of Gleason ≥ 8 prostate cancer patients with higher 18FDG uptake would be ideal candidates for early immunotherapy treatments based on anti-PD-1 such as pembrolizumab.
The study aimed to identify biomarkers predictive the response to Pembrolizumab given prior to radical prostatectomy in participants with primary prostate cancer at high risk of progression.
Read the detailed description
This is a Phase II, single-arm and open-label trial of pembrolizumab (MK-3475) in localized prostate cancer patients with newly diagnosed non-metastatic prostate cancer (Gleason grade ≥8 on biopsy) with positive tumor by FDG-PET (SUV max >4) who chose to undergo radical prostatectomy and lymph node dissection as primary treatment.
The trial will meet its endpoint if a reduction in cancer extent, proliferative index and increased apoptosis, as well as an induction of favorable immune cell infiltration and immune checkpoint expression profiles are observed after treatment compare to baseline..
- Conditions
- Prostate Cancer
- Being tested
- Pembrolizumab
- Keywords
- Prostate Cancer, Pembrolizumab, 18FDG-PET Scanning
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab 200 mg every three weeks for 3 cycles only
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer | Experimental | Participants will receive 3 cycles of pembrolizumab regardless of PD-L1 status. After completion of the second cycle of pembrolizumab treatment, and just before the third injection of pembrolizumab an 18FDG-PET/CT scan will be performed to assess a potential metabolic response. Then between 2 to 4 weeks after the third treatment, subjects will undergo radical prostatectomy. Subjects will be followed every 3 months during the first year post-surgery and according to physician decision during the following years. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The antitumor activity of pembrolizumab assessed as the tumor response rate based on the change in tumor volume as measured by 18FDG-PET
The change in tumor volume will be assessed by change in tumor volume from baseline after 3 cycles of pembrolizumab treatment
Measured: Through study completion, an average of 1 year
Mean difference change in proliferative index in prostate cancer patients between patients treated with pembrolizumab and the control cohort
Proliferative index is measured by Ki67/apoptosis rate
Measured: Through study completion, an average of 1 year
Immune cell infiltration and immune checkpoint expression
Compare large panel of ICP (Immune CheckPoints) ligand expression between patients treated by pembrolizumab and cohort control by imaging mass cytometry
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
One year PSA (Prostate Specific Antigen) failure rate
A statistically significant difference in the 1 year PSA failure rate compared to a historical cohort of untreated patients will indicate that the study has met this secondary objective.
Measured: At the end of study completion, an average of 3 years
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0
Measured: Through study completion, an average of 2 years
Number of participants with decrease in SUV uptake after 3 cycles of pembrolizumab
Measured: Through study completion, an average of 2 years
Assess a possible correlation between deficient mismatched repair (dMMR) and microsatellite instability-high (MSI-H) and response to pembrolizumab.
dMMR and MSI-H status will be determined by immunochemistry and PCR (Polymerase Chain Reaction) respectively
Measured: At the end of study completion, an average of 3 years
Assess the expression of a series of cytokines and eicosanoids
The concentration of 27 cytokines and 37 eicosanoids in tumor sample will be evaluated
Measured: At the end of study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start10 Jan 2020
- Primary completion1 Sep 2024
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Yves Fradet, MD, Principal investigator, CHU de Québec-Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009967
- Sponsor's protocol ID
- 3475-910/OTSP-57
- Acronym
- PICT-01
- Status last verified
- Jan 2025
- First submitted
- 17 Jun 2019
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical and Translational Study of Neoadjuvant Pembrolizumab Before Radical Prostatectomy in Non-metastatic Gleason ≥8 Prostate Cancer Patients Positive by 18FDG-PET Scanning ( PICT-01)
- ClinicalTrials.gov ID
- NCT04009967
- Acronym / sponsor ID
- PICT-01 / 3475-910/OTSP-57
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Pembrolizumab, 18FDG-PET Scanning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 8 Jul 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.
Various approaches are currently being developed for prostate cancer immunotherapy. However, a major challenge facing the development of cancer immunotherapy is the identification of tumors that would best respond to this type of treatment. Different studies suggest that prostate cancer more likely to progress are more infiltrated by exhausted T cells expressing the cell surface protein PD1 (Programmed cell death 1). Therefore, there is a strong rationale for selecting patients at higher risk of progression for testing the efficacy of anti-PD1 therapy.
High glucose metabolism as detected by fludeoxyglucose F18 (FDG)-positron emission tomography (PET) (18FDG-PET) imagery is an innovative biological biomarker-based method to identify patients at higher risk of recurrence and early failure to hormonotherapy. Recent study demonstrated that high intra-prostatic 18-FDG-uptake was associated with higher Gleason grades. Therefore the one third of Gleason ≥ 8 prostate cancer patients with higher 18FDG uptake would be ideal candidates for early immunotherapy treatments based on anti-PD-1 such as pembrolizumab.
The study aimed to identify biomarkers predictive the response to Pembrolizumab given prior to radical prostatectomy in participants with primary prostate cancer at high risk of progression.
Detailed description
This is a Phase II, single-arm and open-label trial of pembrolizumab (MK-3475) in localized prostate cancer patients with newly diagnosed non-metastatic prostate cancer (Gleason grade ≥8 on biopsy) with positive tumor by FDG-PET (SUV max >4) who chose to undergo radical prostatectomy and lymph node dissection as primary treatment.
The trial will meet its endpoint if a reduction in cancer extent, proliferative index and increased apoptosis, as well as an induction of favorable immune cell infiltration and immune checkpoint expression profiles are observed after treatment compare to baseline..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer | Experimental | Drug: PembrolizumabParticipants will receive 3 cycles of pembrolizumab regardless of PD-L1 status. After completion of the second cycle of pembrolizumab treatment, and just before the third injection of pembrolizumab an 18FDG-PET/CT scan will be performed to assess a potential metabolic response. Then between 2 to 4 weeks after the third treatment, subjects will undergo radical prostatectomy. Subjects will be followed every 3 months during the first year post-surgery and according to physician decision during the following years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male Age≥ 18 years old
- Non-metastatic prostate cancer with histologically confirmed Gleason sum ≥8
- Eligible for radical prostatectomy with a delay of 6 to 9 weeks
- Intraprostatic maximum standardized uptake value (SUVmax) ≥4 at 18-FDG-PET/CT exam.
- Not be castrated or under androgen deprivation therapy
Key exclusion criteria (16 listed)
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4 (Cytotoxic T-lymphocyte-Associated Protein 4), OX-40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
- Has received prior radiotherapy to the prostate or other organs within 2 weeks of start of study treatment.
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- Is participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
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 |
|---|---|---|
| PembrolizumabAlso: KeytrudaPembrolizumab 200 mg every three weeks for 3 cycles only | Drug | Prostate Cancer |
Primary outcome
The antitumor activity of pembrolizumab assessed as the tumor response rate based on the change in tumor volume as measured by 18FDG-PET
Time frame: Through study completion, an average of 1 year
The change in tumor volume will be assessed by change in tumor volume from baseline after 3 cycles of pembrolizumab treatment
Mean difference change in proliferative index in prostate cancer patients between patients treated with pembrolizumab and the control cohort
Time frame: Through study completion, an average of 1 year
Proliferative index is measured by Ki67/apoptosis rate
Immune cell infiltration and immune checkpoint expression
Time frame: Through study completion, an average of 1 year
Compare large panel of ICP (Immune CheckPoints) ligand expression between patients treated by pembrolizumab and cohort control by imaging mass cytometry
5 secondary outcomes
One year PSA (Prostate Specific Antigen) failure rate
Time frame: At the end of study completion, an average of 3 years
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0
Time frame: Through study completion, an average of 2 years
Number of participants with decrease in SUV uptake after 3 cycles of pembrolizumab
Time frame: Through study completion, an average of 2 years
Assess a possible correlation between deficient mismatched repair (dMMR) and microsatellite instability-high (MSI-H) and response to pembrolizumab.
Time frame: At the end of study completion, an average of 3 years
Assess the expression of a series of cytokines and eicosanoids
Time frame: At the end of study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Yves Fradet, MD principal investigator
CHU de Québec-Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Prostate Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 9 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 13 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 antitumor activity of pembrolizumab assessed as the tumor response rate based on the change in tumor volume as measured by 18FDG-PET (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 13 Jan 2025.