PSMA-PET CT Imaging for Prostate Cancer

(ESCAPE Trial)

Recruiting at 4 trial locations

Overseen By Sarah Yuan

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Prior treatment, Systemic therapy, Life expectancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will be assessing the ability of PSMA-PET CT to determine the absence of clinically significant prostate cancer in patients on active surveillance (AS) with low risk and favorable intermediate-risk prostate cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment PSMA-PET CT Imaging for Prostate Cancer?

Research shows that 68Ga-PSMA PET/CT is effective in detecting prostate cancer relapses and metastases, helping in accurate staging and planning of radiation therapy. It is also useful in identifying primary prostate cancer, potentially reducing the need for unnecessary biopsies. ^{1 2 3 4 5}

Is PSMA-PET CT Imaging safe for humans?

Research shows that PSMA-PET CT Imaging, specifically using 68Ga-THP PSMA, is generally safe for humans. In a study with 49 patients, no serious adverse events were reported, and only two patients experienced mild side effects like itching and a rash at the injection site. ^{4 6 7 8 9}

How is PSMA-PET CT imaging different from other treatments for prostate cancer?

PSMA-PET CT imaging is unique because it uses a special imaging technique that targets the prostate-specific membrane antigen (PSMA) to provide highly detailed pictures of prostate cancer, helping in accurate diagnosis, staging, and treatment planning. This method is more precise than traditional imaging techniques, potentially reducing the need for invasive procedures like biopsies. ^{2 3 4 7 10}

Research Team

Timothy McClure, M.D.

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

Men over 18 with low or favorable intermediate-risk prostate cancer, as defined by NCCN guidelines, can join. They must have a PSA level under 20 ng/ml and be able to undergo yearly PSMA-PET CT scans, prostate biopsies, and mpMRI. Those not interested in active surveillance or with prior treatments for prostate cancer cannot participate.

Inclusion Criteria

I am a man aged 18 or older.

Ability to complete HRQOL surveys (EPIC, IPSS, IIEF-5)

My prostate cancer is confirmed low or favorable intermediate risk without aggressive features.

Exclusion Criteria

Life expectancy less than 10 years

I do not want to wait and watch my condition without treatment.

I have received systemic therapy for prostate cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo PSMA-PET CT at baseline to assess the absence of clinically significant prostate cancer

1 week

1 visit (in-person)

Monitoring

Participants undergo PSMA-PET CT at 12-month and 24-month time points to monitor prostate cancer status

24 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the 24-month assessment

4 weeks

Treatment Details

Interventions

• PSMA-PET CT

Trial Overview The trial is testing the effectiveness of PSMA-PET CT scans in monitoring patients with low to intermediate-risk prostate cancer who are on active surveillance. The goal is to see if this imaging technique can reliably detect the absence of significant cancer progression.

Participant Groups

Group I: PSMA-PET CT Experimental Treatment 1 Intervention

Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Findings from Research

In a study of 188 patients with rising PSA levels after prostate cancer treatment, 68Ga-PSMA PET/CT demonstrated a high detection rate of 87.8% for tumor relapse, identifying local recurrences and metastases effectively.

The diagnostic accuracy of 68Ga-PSMA PET/CT was exceptional, with sensitivity and specificity rates of 98.8% and 100%, respectively, making it a highly reliable tool for monitoring prostate cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA PET/CT in Patients with Rising Prostatic-Specific Antigen After Definitive Treatment of Prostate Cancer: Detection Efficacy and Diagnostic accuracy. Hamed, MAG., Basha, MAA., Ahmed, H., et al.[2021]

In a study of 108 men with prostate cancer, 68Ga-PSMA PET/CT imaging changed the disease stage in approximately 36% of patients, indicating its effectiveness in improving cancer staging.

The imaging also significantly influenced radiation therapy planning in 31% of patients, leading to adjustments such as the inclusion of stereotactic body radiotherapy for oligometastatic sites and extending radiation fields to cover pelvic lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of 68Ga-prostate-specific membrane antigen PET/computed tomography on prostate cancer staging and planning of definitive radiation therapy. Al-Ibraheem, A., Abuhijla, F., Salah, S., et al.[2023]

99mTechnetium labeled PSMA SPECT-CT imaging is a cost-effective and simpler alternative to Gallium-68 PSMA PET-CT for diagnosing prostate cancer, including detecting primary tumors and metastases.

The study presents a case showing the use of 99mTc-PSMA imaging before therapy and 177Lu-PSMA imaging after therapy, highlighting the potential for effective monitoring of treatment response in prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tc-99m PSMA and Lu-177 PSMA Theranostic Pair in a Patient of Metastatic Castration Resistant Prostate Cancer. Sheikh, N., Younis, MN., Mumtaz, M., et al.[2022]

In a study of 81 patients suspected of prostate cancer, 68Ga-PSMA-PET/CT demonstrated high diagnostic accuracy with a sensitivity of 84% and specificity of 80%, helping to identify malignancies and potentially avoid unnecessary biopsies.

The study established a cut-off SUVmax value of 6.15, below which prostate biopsy may be avoided, indicating that 68Ga-PSMA-PET/CT can effectively localize suspicious lesions and correlate with biopsy results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of 68Ga-PSMA-PET/CT for the detection of primary prostate cancer prior to biopsy: a prospective study. Jain, H., Sood, R., Faridi, MS., et al.[2022]

In a study of 25 patients with untreated intermediate- and high-risk prostate cancer, [68Ga]-PSMA PET/CT demonstrated high diagnostic sensitivity, successfully detecting cancer in all participants and revealing metastatic disease in various locations, including lymph nodes and bones.

The maximum standardized uptake value (SUVmax) of the primary tumor was significantly correlated with serum PSA levels, suggesting that higher SUVmax values may indicate more advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Study on [68Ga]-PSMA PET/CT Imaging in Newly Diagnosed Intermediate- and High-Risk Prostate Cancer. Harsini, S., Fallahi, B., Karamzade Ziarati, N., et al.[2022]

The novel 68Ga-THP PSMA PET/CT imaging technique was found to be safe for use in prostate cancer patients, with no serious adverse events reported and only minor side effects observed in two patients.

This imaging method led to a change in clinical management for 42.9% of the patients evaluated, indicating its potential effectiveness in guiding treatment decisions for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II, Open-label study to assess safety and management change using 68Ga-THP PSMA PET/CT in patients with high risk primary prostate cancer or biochemical recurrence after radical treatment: The PRONOUNCED study. Afaq, A., Payne, H., Davda, R., et al.[2022]

68Ga-PSMA-11 PET/CT has quickly become a valuable tool in prostate cancer imaging, showing high potential for primary diagnosis, staging, and monitoring biochemical recurrence based on numerous studies.

The review aims to summarize key data on 68Ga-PSMA-11 PET/CT and provide recommendations for its use in clinical practice, highlighting its effectiveness in improving patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 PET/CT: the rising star of nuclear medicine in prostate cancer imaging? Uprimny, C.[2021]

(68)Ga-PSMA PET/CT is a highly sensitive diagnostic tool for detecting primary prostate cancer and its metastases, outperforming traditional fluorine-18 choline PET/CT by identifying more metastases at lower PSA levels.

The (68)Ga-PSMA radioligand can be produced in hospitals using a gallium generator, making it a convenient and accessible option for prostate cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Lavalaye, J., Lam, MG., Verzijlbergen, JF., et al.[2021]

[68Ga]Ga-PSMA-11 is a key radiopharmaceutical used for imaging prostate-specific membrane antigen (PSMA), which is crucial for managing recurrent prostate cancer.

The paper provides a comprehensive overview of the preclinical development and clinical applications of [68Ga]Ga-PSMA-11, comparing its effectiveness with other imaging methods to guide clinicians in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[68Ga]Ga-PSMA-11 in prostate cancer: a comprehensive review. Bois, F., Noirot, C., Dietemann, S., et al.[2020]

The study evaluated 42 men with intermediate and high-risk prostate cancer, finding that 68Ga-PSMA PET/CT has high diagnostic accuracy for lymph node staging, with a sensitivity of 85.7% and specificity of 100%.

PSMA PET/CT detected lymph node metastases in 14.3% of patients, aligning closely with histopathological findings, indicating its effectiveness in identifying metastatic disease before radical prostatectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lymph node staging with 68Ga-PSMA PET in patients with intermediate and high-risk prostate cancer suitable for radical prostatectomy managed in a prostate cancer unit. Maestroni, UV., Campobasso, D., Guarino, G., et al.[2023]

References

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

68Ga-PSMA PET/CT in Patients with Rising Prostatic-Specific Antigen After Definitive Treatment of Prostate Cancer: Detection Efficacy and Diagnostic accuracy. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The influence of 68Ga-prostate-specific membrane antigen PET/computed tomography on prostate cancer staging and planning of definitive radiation therapy. [2023]

3. Pakistan pubmed.ncbi.nlm.nih.gov

Tc-99m PSMA and Lu-177 PSMA Theranostic Pair in a Patient of Metastatic Castration Resistant Prostate Cancer. [2022]

4. Poland pubmed.ncbi.nlm.nih.gov

Role of 68Ga-PSMA-PET/CT for the detection of primary prostate cancer prior to biopsy: a prospective study. [2022]

5. Iran pubmed.ncbi.nlm.nih.gov

A Prospective Study on [68Ga]-PSMA PET/CT Imaging in Newly Diagnosed Intermediate- and High-Risk Prostate Cancer. [2022]

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

A Phase II, Open-label study to assess safety and management change using 68Ga-THP PSMA PET/CT in patients with high risk primary prostate cancer or biochemical recurrence after radical treatment: The PRONOUNCED study. [2022]

7. Austria pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 PET/CT: the rising star of nuclear medicine in prostate cancer imaging? [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

[Not Available]. [2021]

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

[68Ga]Ga-PSMA-11 in prostate cancer: a comprehensive review. [2020]

10. China pubmed.ncbi.nlm.nih.gov

Lymph node staging with 68Ga-PSMA PET in patients with intermediate and high-risk prostate cancer suitable for radical prostatectomy managed in a prostate cancer unit. [2023]