PSMA PET/CT Scan for Prostate Cancer

Overseen By Jonathan T Abele, MD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: University of Alberta

Disqualifiers: Consent, Weight, Allergic, Residence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

2800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special imaging scan to detect the spread of prostate cancer. The scan uses a tracer called 18F-PSMA-1007, designed to find cancer that other methods might miss. It targets individuals with a history of prostate cancer treatment, such as surgery or radiation, and specific PSA (prostate-specific antigen) levels. Participants must have undergone prostate cancer treatments and experienced specific PSA changes. The trial also evaluates the safety of the tracer and monitors any side effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking diagnostic tool.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it does mention that androgen deprivation therapy (ADT) is allowed, so you can continue that treatment if applicable.

What prior data suggests that the 18F-PSMA-1007 PET/CT scan is safe for prostate cancer patients?

Research shows that 18F-PSMA-1007, a substance used in PET/CT scans for prostate cancer, is generally safe for patients. Studies comparing it to MRI have demonstrated its effectiveness in detecting prostate cancer and have provided some information about its safety.

Previous research has reported no major serious side effects from using 18F-PSMA-1007, suggesting it is relatively safe. However, participants in trials like this one are closely monitored for any side effects immediately after receiving the tracer and following the scan. They can also report any side effects that occur later.

Overall, current evidence suggests that 18F-PSMA-1007 is a safe choice for imaging in prostate cancer cases, with only minor side effects expected, if any. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-PSMA-1007 because it offers a new way to detect prostate cancer using a PET/CT scan. Unlike traditional methods that often rely on a combination of PSA tests, biopsies, and bone scans, 18F-PSMA-1007 is a radiotracer that specifically targets PSMA, a protein commonly found on prostate cancer cells. This allows for more precise imaging, potentially leading to earlier and more accurate detection of tumors. Additionally, it may reduce the need for invasive procedures, offering a less burdensome option for patients.

What evidence suggests that the 18F-PSMA-1007 PET/CT scan is effective for prostate cancer?

Studies have shown that the 18F-PSMA-1007 PET/CT scan, which participants in this trial will receive, surpasses MRI in detecting prostate cancer in the body. This imaging method provides more accurate diagnosis and staging of prostate cancer, enabling doctors to locate the cancer more reliably. Research indicates that 18F-PSMA-1007 PET/CT outperforms multiparametric MRI, a common imaging technique. This scan is also highly sensitive, detecting even small amounts of cancer accurately. Overall, evidence suggests that 18F-PSMA-1007 PET/CT is a promising tool for finding and evaluating prostate cancer. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults with prostate cancer who've had surgery or other treatments like radiotherapy, and now have rising PSA levels or high-risk features indicating possible metastatic disease. It's also open to those where a PET/CT scan might help in their care as decided by certain specialists in Alberta.

Inclusion Criteria

I have prostate cancer with a high Gleason score, high PSA, or advanced stage.

Adult patients who do not meet criteria 1-3 but in whom a 18F-PSMA-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta)

I've had prostate cancer treatment and my PSA is rising or doubling quickly.

Exclusion Criteria

Lack of intravenous access

Unable to obtain consent

Weight > 225 kg (weight limit of PET/CT scanners)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Tracer Injection and Immediate Safety Assessment

Participants receive a single dose of 18F-PSMA-1007 and are screened for adverse effects immediately post-injection

1 day

1 visit (in-person)

Post-Scan Safety Assessment

Participants are screened for adverse effects immediately after the PET/CT scan, approximately 2.5 hours after tracer injection

1 day

1 visit (in-person)

Delayed Safety Monitoring

Participants are provided with information to self-report any delayed adverse events occurring 1-7 days post-injection

1 week

Follow-up

Participants' non-specific bone lesions are evaluated to determine if they are benign or malignant, based on reference standards

1 year

What Are the Treatments Tested in This Trial?

Interventions

• 18F-PSMA-1007

Trial Overview The study tests the safety and effectiveness of a new imaging tracer called 18F-PSMA-1007 used in PET/CT scans. It aims to improve detection of prostate cancer spread, especially evaluating non-specific bone lesions to see if they're benign or malignant.

How Is the Trial Designed?

Group I: 18F-PSMA-1007 Experimental Treatment 1 Intervention

18F-PSMA-1007, 4 MBq/kg (max 400 MBq; +/- 15%), intravenous, single dose

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

The new PET tracer 18F-PSMA-1007 shows promising results for detecting prostate cancer, with an effective dose similar to other PSMA-targeting agents and significantly reduced urinary clearance, allowing for better imaging of the prostate.

In a study involving 10 patients with high-risk prostate cancer, 18F-PSMA-1007 successfully detected 18 out of 19 lymph node metastases, demonstrating its efficacy in identifying small tumors and validating its diagnostic capabilities with histopathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients. Giesel, FL., Hadaschik, B., Cardinale, J., et al.[2023]

In a study of 99 men with intermediate- or high-risk prostate cancer, 18F-PSMA-1007 PET/CT demonstrated high specificity (89.9%) for detecting lymph node involvement (LNI), but only moderate sensitivity (53.3%), indicating it is good at confirming the absence of disease but less effective at detecting it.

The results suggest that while 18F-PSMA-1007 PET/CT can provide useful information, it should not replace extended pelvic lymph node dissection (ePLND) for accurate staging in these patients, highlighting the need for further research to refine its role in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lymph node staging with fluorine-18 prostate specific membrane antigen 1007-positron emission tomography/computed tomography in newly diagnosed intermediate- to high-risk prostate cancer using histopathological evaluation of extended pelvic node dissection as reference. Hermsen, R., Wedick, EBC., Vinken, MJM., et al.[2022]

In a study involving 12 prostate cancer patients, the new tracer 18 F-PSMA-1007 demonstrated high uptake in organs such as the liver, kidneys, and salivary glands, indicating its potential effectiveness for imaging prostate cancer.

The effective radiation dose from 18 F-PSMA-1007 was calculated to be between 6.0-8.0 mSv for an average patient, which provides important safety information for its use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biokinetics and dosimetry of 18 F-PSMA-1007 in patients with prostate cancer. Hvittfeldt, E., Bjöersdorff, M., Brolin, G., et al.[2023]

In a study of 100 patients with recurrent prostate cancer, 95% showed at least one pathological finding using 18F-PSMA-1007 PET/CT, indicating its high diagnostic performance for detecting recurrence.

The 18F-PSMA-1007 PET/CT scan was effective even in patients with low PSA levels (≤0.5 ng/ml), suggesting it could significantly influence treatment decisions for patients with biochemical relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 18F-PSMA-1007 PET/CT in patients with biochemical recurrent prostate cancer. Rahbar, K., Afshar-Oromieh, A., Seifert, R., et al.[2019]

In a study of 71 prostate cancer patients with biochemical recurrence after surgery, 79% showed at least one abnormal finding using 18F-PSMA-1007 PET/CT, indicating its effectiveness in detecting cancer even at low PSA levels.

The detection rate increased with higher PSA levels and Gleason scores, suggesting that 18F-PSMA-1007 PET/CT is a valuable tool for clinical management in prostate cancer patients, particularly those with rising PSA levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of 18F-PSMA-1007 PET/CT in prostate cancer patients with biochemical recurrence after radical prostatectomy. Zhou, X., Jiang, X., Liu, L., et al.[2021]

F-PSMA-1007 PET/CT imaging effectively identified prostate cancer and multiple bone metastases in a 77-year-old patient, but also revealed a primary liver cancer, highlighting its potential for detecting additional diseases beyond prostate cancer.

The case emphasizes the importance of careful interpretation of PSMA-PET/CT results, as increased tracer uptake in unexpected lesions may indicate other conditions, necessitating further pathological examination for accurate diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidental detection of primary hepatocellular carcinoma on 18F-prostate-specific membrane antigen-1007 positron emission tomography/computed tomography imaging in a patient with prostate cancer: A case report. Zhao, H., Li, Y., Hou, S., et al.[2022]

The study analyzed 125 prostate cancer lesions from 80 patients and found that higher SUVmax values from 18F-PSMA-1007 PET/CT scans significantly correlated with higher ISUP grade groups, indicating more aggressive cancer.

A SUVmax threshold of 4 was identified, which would only miss 2% of clinically significant prostate cancer lesions, suggesting that this imaging technique could effectively characterize the severity of intraprostatic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunohistochemical and histopathological validation of 18 F-PSMA-1007 PET/CT for intraprostatic cancerous lesions. Heetman, JG., Hermsen, R., Exterkate, L., et al.[2023]

PSMA-based PET-CT imaging using fluorine-18 PSMA-1007 is effective for staging high-risk prostate cancer and locating recurrent disease, offering advantages like hepatobiliary excretion and a longer half-life compared to gallium tracers.

Despite its benefits, there are still some ambiguities and potential pitfalls in interpreting the results of PSMA-1007 imaging, which need to be considered in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorine-18 labelled prostate-specific membrane antigen (PSMA)-1007 positron-emission tomography-computed tomography: normal patterns, pearls, and pitfalls. Foley, RW., Redman, SL., Graham, RN., et al.[2021]

The PET tracer 18F-PSMA 1007 was found to be safe and well tolerated in both healthy volunteers and prostate cancer patients, with no serious adverse events reported during the study.

In terms of diagnostic effectiveness, 18F-PSMA 1007 demonstrated high accuracy in detecting prostate cancer, achieving a sensitivity of 80% and a positive predictive value of 100% in patients with untreated preoperative prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/IIa trial of 18F-prostate specific membrane antigen (PSMA) 1007 PET/CT in healthy volunteers and prostate cancer patients. Tateishi, U., Kimura, K., Tsuchiya, J., et al.[2023]

F-18-PSMA-1007-PET is effective for staging prostate cancer, particularly in identifying seminal vesicle invasion, outperforming mpMRI with a correct staging rate of 90% compared to 76%.

The study suggests that combining F-18-PSMA-1007-PET with mpMRI could enhance the overall accuracy of prostate cancer staging, as mpMRI was better at detecting extracapsular extension (90% vs. 57%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating F-18-PSMA-1007-PET in primary prostate cancer and comparing it to multi-parametric MRI and histopathology. Privé, BM., Israël, B., Schilham, MGM., et al.[2022]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2820678

Fluorine-18 PSMA-1007 PET/CT vs Multiparametric MRI for ... In this prospective paired cohort study, 18F-PSMA-1007 PET/CT provided improved accuracy compared with multiparametric MRI for prostate cancer ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/early/2025/10/23/jnumed.125.269818

Efficacy of [18F]PSMA-1007 PET/CT in Primary Staging of ... Fluorine-18 prostate-specific membrane antigen-1007 PET/CT vs multiparametric MRI for locoregional staging of prostate cancer. JAMA. Oncol ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38949926/

Fluorine-18 Prostate-Specific Membrane Antigen-1007 ... In this phase 2 prospective validating paired cohort study, 18F-PSMA-1007 PET/CT was superior to MRI for the locoregional staging of prostate cancer.

4. nature.com nature.com/articles/s41416-024-02934-x

The accuracy of fluorine 18-labelled prostate-specific ... F-PSMA-1007 PET/CT demonstrated better diagnostic performance for PCa than mpMRI (AUC 0.81 vs. 0.63, P = 0.02). 11.0% of patients with PI-RADS 3 ...

5. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.231879

Multiparametric MRI and 18F-PSMA-1007 PET/CT for the ... 18 F-PSMA-1007 PET/CT showed good sensitivity and moderate specificity for the detection of csPCa and ruled this out in 93% of participants with PI-RADS 3 ...