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

Trial Summary

What is the purpose of this trial?

A two-centre prospective cohort phase III study of 18F-PSMA-1007 PET/CT imaging in specific patient populations: 1. Adults patients (≥18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L 2. Adult patients with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of \< 9 months 3. Adult patients with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c 4. Adult patients who do not meet criteria 1-3 but in whom a 18F-PDAM-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) The safety of the investigational 18F-PSMA-1007 tracer will be evaluated in 3 ways: 1. The participant will be screened for adverse effects immediately post-injection 2. The participant will be screened for adverse effects immediately after the scan (approximately 2.5 hours after tracer injection) 3. The participant will be provided an information sheet and contact information for self-reporting of any delayed adverse events (1-7 days post injection) The incidence of and activity of non-specific bone lesions will be quantified and evaluated as follows: 1. All lesions categorized as non-specific bone lesions (PSMA-1007 SUVmax \> 2.5 but no corresponding lesion on CT) will be recorded 2. The SUVmax and anatomic location will be recorded for each lesion (max 5 per participant) 3. Recorded lesions will be evaluated a minimum of 1 year post-scan to determine whether they are benign or malignant based on previously published reference standard criteria (Arnfield et al., 2021) 4. Equivocal lesions will be considered unevaluable and will be excluded from assessment of accuracy

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 data supports the effectiveness of the treatment 18F-PSMA-1007 PET/CT for prostate cancer?

Research shows that 18F-PSMA-1007 PET/CT is effective in staging prostate cancer, especially in high-risk cases and in detecting recurrent disease after initial treatment. It is advantageous because it can be produced in larger quantities and has a longer shelf life, making it more accessible for patients. ^{1 2 3 4 5}

Is the 18F-PSMA-1007 PET/CT scan safe for humans?

The 18F-PSMA-1007 PET/CT scan has been studied for safety in both healthy volunteers and prostate cancer patients, and it is generally considered safe for human use. The studies focused on its biodistribution (how it spreads in the body) and radiation dosimetry (measurement of radiation exposure), indicating it is well-tolerated. ^{4 5 6 7 8}

How is the PSMA PET/CT scan treatment for prostate cancer different from other treatments?

The PSMA PET/CT scan for prostate cancer is unique because it uses a special radiotracer, fluorine-18 PSMA-1007, which is not excreted through the kidneys, allowing for clearer imaging of the pelvic area. This makes it particularly useful for staging high-risk prostate cancer and locating recurrent disease, offering advantages over other imaging methods like multi-parametric MRI. ^{3 4 5 9 10}

Eligibility Criteria

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 am an adult who had surgery for prostate cancer and my PSA level is at least 0.2 mcg/L.

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)

Exclusion Criteria

Lack of intravenous access

Unable to obtain consent

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 18F-PSMA-1007 PET/CT in patients with biochemical recurrent prostate cancer. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of 18F-PSMA-1007 PET/CT in prostate cancer patients with biochemical recurrence after radical prostatectomy. [2021]

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Fluorine-18 labelled prostate-specific membrane antigen (PSMA)-1007 positron-emission tomography-computed tomography: normal patterns, pearls, and pitfalls. [2021]

5. Germany 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. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients. [2023]

7. England 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Biokinetics and dosimetry of 18 F-PSMA-1007 in patients with prostate cancer. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Immunohistochemical and histopathological validation of 18 F-PSMA-1007 PET/CT for intraprostatic cancerous lesions. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Evaluating F-18-PSMA-1007-PET in primary prostate cancer and comparing it to multi-parametric MRI and histopathology. [2022]