PSMA PET Imaging for Prostate Cancer

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

1171 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see if a new diagnostic research agent named 68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other standard imaging even when the PSA levels are very low.

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 data supports the effectiveness of the treatment 68Ga-HBED-CC-PSMA for prostate cancer?

Research shows that 68Ga-HBED-CC-PSMA is effective in detecting prostate cancer and its recurrence, with higher accuracy than traditional CT scans. It has a high detection rate for localizing cancer sites, especially in patients with biochemical recurrence, and is more effective than other imaging methods like (18)F-Fluoroethylcholine PET/CT. ^{1 2 3 4 5}

Is PSMA PET Imaging for Prostate Cancer safe for humans?

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 studies have focused on understanding how the tracer spreads in the body and the radiation dose patients receive, which are important for ensuring safety. ^{6 7 8 9 10}

How does PSMA PET Imaging for Prostate Cancer differ from other treatments?

PSMA PET Imaging for Prostate Cancer uses a novel tracer called 68Ga-PSMA, which is highly effective in detecting prostate cancer recurrence and metastases. This imaging technique is more sensitive and accurate than traditional CT scans, particularly in identifying nodal and skeletal metastases, making it a valuable tool for precise cancer localization. ^{1 3 4 5 11}

Research Team

Heiko Schöder, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

I was first treated with surgery or specific types of therapy for my condition.

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

References

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

68Ga-PSMA PET/CT Detects the Location and Extent of Primary Prostate Cancer. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

PSA levels, PSA doubling time, Gleason score and prior therapy cannot predict measured uptake of [68Ga]PSMA-HBED-CC lesion uptake in recurrent/metastatic prostate cancer. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Initial experience of Ga-68 prostate-specific membrane antigen positron emission tomography/computed tomography imaging in evaluation of biochemical recurrence in prostate cancer patients. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Detection of recurrent prostate cancer lesions before salvage lymphadenectomy is more accurate with (68)Ga-PSMA-HBED-CC than with (18)F-Fluoroethylcholine PET/CT. [2021]

5. Netherlands 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. [2022]

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

Radiation dosimetry of [68Ga]PSMA-11 in low-risk prostate cancer patients. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Radiation dosimetry of (68)Ga-PSMA-11 (HBED-CC) and preliminary evaluation of optimal imaging timing. [2021]

8. 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]

9. Germany pubmed.ncbi.nlm.nih.gov

Biodistribution and radiation dosimetry of (68)Ga-PSMA HBED CC-a PSMA specific probe for PET imaging of prostate cancer. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

[Procedure Guideline for Prostate Cancer Imaging with PSMA-ligand PET/CT]. [2023]

11. Germany 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. [2022]