PET Imaging for Prostate Cancer
(4TMPO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a special imaging technique called PET, which uses tracers to assess the activity of prostate cancer cells in various body parts. The goal is to track how each cancer spot (metastasis) responds to treatment, aiding doctors in identifying spots that might resist therapy. This could help tailor treatments more effectively for patients with metastatic prostate cancer. Men with prostate cancer that has spread to at least three different spots and who have tried certain treatments without success might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to developing personalized treatment strategies for prostate cancer.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that PET imaging is safe for prostate cancer patients?
Research has shown that PET tracers, like those used in this study, are generally safe. In one study, a tracer called 68Ga-THP PSMA was safe, with no serious side effects reported, and no participants left the study due to side effects. Another study found that a different tracer, 64Cu-SAR-bisPSMA, was also safe and effective at detecting cancer cells. It was well-tolerated, meaning participants did not experience significant side effects. Overall, these findings suggest that PET tracers used for imaging in prostate cancer are safe and carry few risks.12345
Why are researchers excited about this trial?
Researchers are excited about using PET Tracers like FDG, PSMA, and DOTATATE in prostate cancer imaging because they offer a more precise and detailed look at cancer cells compared to traditional imaging methods. Unlike standard imaging techniques, these PET Tracers specifically target cancerous cells, which helps in detecting even small or hidden tumors. This targeted approach not only potentially improves the accuracy of prostate cancer diagnosis but also aids in better treatment planning, offering hope for more personalized and effective patient care.
What evidence suggests that PET imaging is effective for prostate cancer?
Research has shown that PET scans using special tracers like FDG, PSMA, and DOTATATE can be very useful for prostate cancer. These tracers detect cancer activity in each tumor, providing more detailed information than regular imaging methods. In this trial, participants will undergo PET imaging with these tracers. Specifically, PSMA PET/CT scans excel at identifying the spread of prostate cancer. One study found that using PSMA PET/CT to assess treatment effectiveness predicted patient survival better than traditional PSA tests. This suggests that PET scans could help doctors evaluate how prostate cancer responds to treatment and adjust therapies more effectively.678910
Who Is on the Research Team?
Frédéric Pouliot, MD, PhD
Principal Investigator
CHU de Québec-Université Laval
Are You a Good Fit for This Trial?
This trial is for individuals assigned male at birth, any gender, aged 18 or older with histologically proven metastatic prostate cancer. Participants must have at least three active lesions visible on bone scan or CT-scan and show progression despite castration and ARPI treatment. They should be eligible for taxane chemotherapy or PSMA-radioligand therapy and able to consent to the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial PET Imaging
Participants undergo initial triple tracer PET molecular imaging using 18F-FDG, 68Ga-PSMA, and 68Ga-DOTATATE
Treatment
Participants receive systemic therapy with cabazitaxel, docetaxel, ARPI, or PSMA-radioligand therapy
Follow-up Imaging and Biopsy
Double-tracer PET/CT imaging performed and biopsy of a progressive lesion executed after first progression
Second Line Treatment
Participants receive a mandatory second line of approved mCRPC systemic therapies
Follow-up Imaging and Optional Biopsy
Double-tracer PET/CT imaging repeated and optional biopsy of a non-progressing site offered after second progression
Long-term Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PET Tracer
Trial Overview
The study uses PET imaging with tracers to measure activity in prostate cancer cells across multiple metastases before treatment, after 3 months, and upon progression during systemic therapy. It aims to understand resistance mechanisms by analyzing gene expression in responding versus non-responding metastases.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Frederic Pouliot
Lead Sponsor
Citations
Prognostic value of FDG, PSMA, and DOTATATE uptake ...
Conclusions: mCRPC patients harboring FDG+/PSMA- lesion(s) had a shorter OS than those who did not, and their prognosis was even poorer if they ...
Long-Term Outcomes of Prostate-Specific Membrane ...
This decision analytic modeling study estimates the long-term outcomes of prostate-specific membrane antigen positron emission tomography ...
Efficacy of [18F]PSMA-1007 PET/CT in Primary Staging of ...
Conclusion: PET/CT imaging with [18F]PSMA-1007 provides high sensitivity and specificity in T, N, and M staging of PCa when compared with ...
PSMA PET/CT for treatment response evaluation at ...
PSMA PET/CT for assessing treatment response at predefined time points was superior to PSA-based response for predicting overall survival in mCRPC patients.
Addressing Knowledge Gaps and Clinical Challenges of ...
PSMA PET total tumor volume predicts outcome of patients with advanced prostate cancer receiving [(177)Lu]Lu-PSMA-617 radioligand therapy in ...
A Phase II, Open-Label Study to Assess Safety and ...
Conclusion: 68Ga-THP PSMA was safe to use, with no serious AEs and no AEs resulting in withdrawal from the study. 68Ga-THP PSMA PET/CT changed the management of ...
7.
auntminnie.com
auntminnie.com/clinical-news/molecular-imaging/article/15773722/phase-i-trial-reveals-the-potential-of-a-new-psmapet-tracerPhase I trial reveals the potential of a new PSMA-PET tracer
“A phase II trial of Cu-61 PSMA I&T has been designed to continue obtaining safety data for the radiotracer and to statistically determine ...
PSMA PET scan for prostate cancer
A PSMA PET scan is a safe imaging test. Like all tests, it has some risks, limitations and side effects. These include side effects related to ...
New PET Imaging Tracers for the Primary Staging of ...
Overall, this phase I trial demonstrated that 64Cu-SAR-bisPSMA was safe and effective for detecting PSMA-expressing lesions, with 200 MBq of 64Cu-SAR-bisPSMA ...
Safety, Dosimetry, and Feasibility of [68Ga]Ga-PSMA-R2 ...
Conclusion: 68Ga-PSMA-R2 was well tolerated, with no drug-related treatment-emergent adverse events. Safety and preliminary imaging performance ...
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