PSMA PET Imaging for Prostate Cancer

Not currently recruiting at 9 trial locations

Overseen By Michael Zelefsky, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Claustrophobia, others

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

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent, 68Ga-HBED-CC-PSMA, a radiotracer for PET scans, to determine if it can detect prostate cancer on PET/CT scans when standard scans fail, even with low PSA levels. The trial employs two approaches: one combines the PET scan with either a CT scan or an MRI, while the other uses an MRI unless a CT scan is necessary. Men diagnosed with prostate cancer who have undergone treatments like surgery or radiation, and have specific PSA levels, might be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this diagnostic agent is safe for prostate cancer imaging?

Research has shown that 68Ga-HBED-CC-PSMA is generally safe for people. Studies have found that this tracer, used in specialized PET scans for prostate cancer, is well-tolerated. The primary concern is the radiation dose, which measures 0.022 mSv per MBq. The kidneys and tear-producing glands receive the highest doses, but these levels remain within safe limits. Overall, 68Ga-PSMA-11 is gaining popularity because it allows doctors to see prostate cancer more clearly than some standard scans. This makes it a valuable tool in cancer management with a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PSMA PET Imaging technique because it offers a more precise way to detect prostate cancer compared to traditional imaging methods. Unlike standard imaging techniques, such as bone scans or CTs, this approach uses a compound called 68Ga-HBED-CC-PSMA that specifically targets prostate-specific membrane antigen (PSMA), which is often found in higher amounts on prostate cancer cells. This targeted imaging helps in identifying cancer spread with higher accuracy and potentially at an earlier stage, allowing for more tailored treatment plans. Additionally, the flexibility of using either PET/CT or PET/MRI gives clinicians more options to choose the best imaging method based on availability and patient needs.

What evidence suggests that this diagnostic agent is effective for detecting prostate cancer?

Research has shown that 68Ga-HBED-CC-PSMA effectively detects prostate cancer. Studies have demonstrated that this imaging agent can accurately locate and assess the spread of prostate cancer, even at very low PSA levels. By targeting a specific protein in prostate cancer cells, it makes them visible on a PET/CT scan. This trial will evaluate the effectiveness of 68Ga-HBED-CC-PSMA PET imaging combined with either CT or MRI, helping doctors identify cancer that regular imaging methods might miss. With this capability, 68Ga-PSMA PET/CT can enhance the staging and monitoring of prostate cancer. ^{5 6 7 8 9}

Who Is on the Research Team?

Heiko Schöder, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for men over 18 with biopsy-proven prostate adenocarcinoma, whose PSA levels have risen by at least 2 ng/ml after initial treatments like surgery or radiation. They must be able to undergo PET/CT scans and not have claustrophobia or other issues that would make such imaging difficult.

Inclusion Criteria

You need to be able to undergo a PET/CT or PET/MR scan without any problems.

I had surgery or radiation (or both) as my first cancer treatment.

PSA ≥ 2 ng/ml above the most recent therapy nadir

Exclusion Criteria

Patient with claustrophobia that would preclude PET/CT or PET/MR imaging or other contraindications to CT imaging.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET scan with Ga-HBED-iPSMA, possibly combined with CT or MRI

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after imaging

2 years

What Are the Treatments Tested in This Trial?

Interventions

• 68Ga-HBED-CC-PSMA

Trial Overview The study tests a new diagnostic agent called 68Ga-HBED-CC-PSMA in detecting recurrent prostate cancer on PET/CT scans, especially when PSA levels are low but rising, indicating potential cancer activity.

How Is the Trial Designed?

Group I: Ga-HBED-iPSMA PET with CT or MRI Active Control 3 Interventions

Participants will have a PET scan with Ga-HBED-iPSMA. PET may be combined with CT or MRI at the discretion of the referring clinician.

Group II: Ga-HBED-iPSMA PET with MRI Active Control 2 Interventions

Participants will have a PET scan with Ga-HBED-iPSMA and will be combined with MRI. If PET/MR imaging is not available, PET/CT imaging may be substituted. This arm will be closed to accrual and these patients will be analyzed separately.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

68Ga-PSMA PET/CT is highly effective for detecting recurrent prostate cancer, identifying cancer sites in 81% of patients with rising PSA levels after treatment, and showing a 50% detection rate for PSA levels between 0.2-0.49 ng/ml.

The imaging method demonstrated no reported adverse effects, making it a safe option for patients, and it outperformed traditional imaging methods like bone scans in detecting early recurrence of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-Labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Computed Tomography for Prostate Cancer: A Systematic Review and Meta-analysis. von Eyben, FE., Picchio, M., von Eyben, R., et al.[2022]

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]

The effective dose of [68Ga]PSMA-11 for imaging prostate cancer is 0.022 mSv/MBq, indicating a relatively low radiation exposure for patients.

In a study of six low-risk prostate cancer patients, the kidneys received the highest organ dose at approximately 40 mGy after a typical injection, while the eye lenses received a very low dose of 0.0051 mGy/MBq, suggesting a favorable safety profile for this imaging agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation dosimetry of [68Ga]PSMA-11 in low-risk prostate cancer patients. Sandgren, K., Johansson, L., Axelsson, J., et al.[2020]

The study involving 20 patients demonstrated that (68)Ga-PSMA PET/MRI is more effective than PET/CT for detecting recurrent prostate cancer, providing clearer images and better characterization of unclear findings.

PET/MRI resulted in lower radiation exposure compared to PET/CT, although it presented challenges in scatter correction and differences in standardized uptake values (SUVs) between the two imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of PET/CT and PET/MRI hybrid systems using a 68Ga-labelled PSMA ligand for the diagnosis of recurrent prostate cancer: initial experience. Afshar-Oromieh, A., Haberkorn, U., Schlemmer, HP., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5871999/

Review of Gallium-68 PSMA PET/CT Imaging in the ... 68 Ga-PSMA PET/CT has the ability to reliably stage prostate cancer at presentation and can help inform an optimal treatment approach.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6715755/

[68Ga]Ga-PSMA-11 PET/CT for monitoring response to ... The aim of this study was to retrospectively assess whether and to what extent PSMA PET/CT studies add clinically relevant data to those of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03389451

68Ga PSMA PET for Patients With Biochemical Recurrence ... This study investigates if a new prostate-specific membrane antigen (PSMA) drug makes prostate cancer easier to identify in positron-emission tomography ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/early/2016/06/01/jnumed.116.172627

68Ga-PSMA-HBED-CC PET/CT detects location and extent of ... Conclusion: 68Ga-PSMA PET/CT accurately detects location and extent of primary prostate cancer. Our preliminary findings warrant further ...

5. link.springer.com link.springer.com/article/10.1007/s00259-024-06887-4

Correlation of [68Ga]Ga-PSMA PET/CT response and PSA ... It has been shown that enzalutamide is able to induce PSMA upregulation in mCRPC patients, as assessed by PSMA PET scan performed at baseline ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6328430/

Radiation dosimetry of [68Ga]PSMA-11 in low-risk prostate ... The effective dose for [ 68 Ga]PSMA-11 is 0.022 mSv/MBq, where the kidneys and lacrimal glands receiving the highest organ dose.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04243941

PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer The goal of this study is to determine the safety of using PSMA-PET/mpMRI to define radiotherapy targets, while meeting all current planning criteria. This ...

8. jnm.snmjournals.org jnm.snmjournals.org/content/58/12/1956

Impact of 68 Ga-PSMA-11 PET on Management in Patients ... 68 Ga-PSMA-11 PET resulted in a major change in management in 53% of patients with biochemical recurrence.

9. withpower.com withpower.com/trial/phase-3-prostatic-neoplasms-5-2017-70e69

PSMA PET Imaging for Prostate Cancer · Info for Participants Studies on 68Ga-PSMA-11, a tracer used in PSMA PET imaging, have been conducted to assess its safety, showing that it is generally safe for human use. These ...