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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special imaging technique called PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) to determine if it can accurately show the absence of significant prostate cancer in men with low to medium-risk prostate cancer who are under active surveillance. The goal is to assess whether this imaging can replace or reduce the need for more invasive procedures. Men diagnosed with low or favorable intermediate-risk prostate cancer who haven't received previous treatment might be suitable candidates. Participants should be prepared to undergo this imaging and other related procedures, such as prostate biopsies, regularly over the next couple of years. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could lead to less invasive monitoring options for 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 prior data suggests that PSMA-PET CT imaging is safe for prostate cancer patients?

Research has shown that PSMA-PET CT is generally safe for patients. Studies have found this imaging method to be well-tolerated, with no major safety issues reported.

One study focused on using PSMA-PET CT to detect prostate cancer and found it safe and effective. Another study confirmed that using PSMA-PET CT to guide biopsies was safe and successful in diagnosing prostate cancer.

Overall, these findings suggest that PSMA-PET CT is a safe imaging option for patients with prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PSMA-PET CT imaging for prostate cancer because it offers a more precise way to detect and monitor the disease compared to traditional imaging methods like bone scans or CT scans. This technique uses a special tracer that binds to the Prostate Specific Membrane Antigen (PSMA), which is often present in higher amounts on prostate cancer cells. This targeting ability means PSMA-PET CT can potentially reveal cancer spread earlier and more accurately, helping doctors tailor treatment plans more effectively. It represents a significant advancement in visualizing the disease, offering the promise of improved outcomes for patients.

What evidence suggests that PSMA-PET CT is effective for detecting prostate cancer?

Research has shown that PSMA-PET CT, which participants in this trial will undergo, effectively detects prostate cancer. Studies have demonstrated that this scan can identify cancer even when PSA levels are very low. In 45% of cases, PSMA-PET CT found more cancer than expected, a phenomenon known as "upstaging." The FDA has approved this tool for enhancing prostate cancer diagnosis and treatment. Overall, PSMA-PET CT is highly sensitive, meaning it can detect cancer that other methods might miss. ^{4 6 7 8 9}

Who Is on the Research Team?

Timothy McClure, M.D.

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

[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]

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]

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]

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]

(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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11394562/

Comparative Performance of 68Ga-PSMA-11 PET/CT and ...

Overall, PSMA-PET/CT led to a TNM upstaging in 45.0% (27/60) of cases, with no evidence of downstaging, resulting in a change in management in ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10000220/

Detection Efficacy of 68Ga-PSMA-11 PET/CT in ...

We analyzed two academic institutions' ~7-year “real-world” experience with 68 Ga-PSMA-11 PET/CT in 115 prostatectomized men with BCR with very low PSA (≤0.2 ...

3.

radiology.ucsf.edu

radiology.ucsf.edu/psma-pet-scan-for-prostate-cancer

PSMA PET Scan for Prostate Cancer

The new FDA-approved prostate-specific membrane antigen (PSMA) PET imaging scan significantly improves prostate cancer detection and treatment.

4.

jnm.snmjournals.org

jnm.snmjournals.org/content/65/3/379

Diagnostic Performance of 68Ga-PSMA-11 PET/CT Versus ...

For detecting intraprostatic radiorecurrence, 68 Ga-PSMA-11 PET/CT has high sensitivity that is not significantly different from mpMRI.

5.

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 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34546815/

68 Ga-Prostate-Specific Membrane Antigen Positron ...

SUVmax on 68 Ga-PSMA PET/CT is associated with GP4. SUVmax may improve risk stratification for men with intermediate-risk prostate cancer.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35191735/

Safety and Diagnostic Yield of 68 Ga Prostate-specific ...

Transgluteal prostate-specific membrane antigen (PSMA) PET/CT-guided, robotic-targeted prostatic biopsy is safe with a high diagnostic yield of prostate cancer ...

8.

jamanetwork.com

jamanetwork.com/journals/jamaoncology/fullarticle/2797264

PSMA PET Scan | Oncology

A prostate-specific membrane antigen positron emission tomography (PSMA PET) scan is an imaging test used to detect prostate cancer throughout the body.

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S0302283825004828

SPARC: The Standardised Prostate-specific Membrane ...

Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) is an evolving diagnostic tool for ...