PSMA-11 PET/CT Imaging for Recurrent Prostate Cancer

(PSMA SRT Trial)

Not currently recruiting at 1 trial location

Age: Any Age

Sex: Male

Trial Phase: Phase 3

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Androgen deprivation therapy

Disqualifiers: Extra-pelvic metastasis, Inflammatory bowel disease, 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 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging technique called Gallium Ga 68-labeled PSMA-11 PET/CT to diagnose prostate cancer that has returned after surgery. The goal is to determine if this imaging method can more accurately locate the cancer, aiding doctors in planning more effective radiation treatment. It targets individuals who have undergone prostate cancer surgery, whose cancer has recurred, and who plan to undergo radiation therapy. Participants must have a PSA level of at least 0.1 ng/ml and agree to use the imaging results to guide their treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking diagnostic advancement.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had androgen deprivation therapy (a treatment to lower male hormones) within 3 months before the PET/CT scan. Also, you cannot be on any investigational drugs for prostate cancer during the trial.

What prior data suggests that this diagnostic method is safe for detecting recurrent prostate cancer?

Research has shown that Gallium Ga 68-labeled PSMA-11, used in PET/CT scans, is generally safe for diagnosing recurrent prostate cancer. Studies have found that patients tolerate this imaging agent well. The FDA has approved it for this purpose, confirming it has passed strict safety tests for detecting prostate cancer.

In earlier research, reported side effects were mild and temporary, such as slight discomfort at the injection site or minor changes in taste. No serious side effects have been linked to this agent in these studies. Overall, evidence suggests that Gallium Ga 68-labeled PSMA-11 is a safe option to help doctors plan treatment for recurrent prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Gallium Ga 68-labeled PSMA-11 for imaging in recurrent prostate cancer because it offers a new way to detect cancer cells more precisely. Unlike the standard imaging techniques, this method uses a radioactive tracer that specifically binds to PSMA, a protein highly expressed in prostate cancer cells. This allows for clearer PET/CT scans, potentially leading to more accurate diagnoses and tailored treatment plans. By providing a detailed view of cancer spread, it could improve the effectiveness of subsequent treatments, making it a promising tool for managing recurrent prostate cancer.

What evidence suggests that 68Ga-PSMA-11 PET/CT is effective for diagnosing recurrent prostate cancer?

Research has shown that Gallium Ga 68-labeled PSMA-11, when used with PET/CT scans, effectively detects recurrent prostate cancer. One study found that this scan identified cancer in cases where other imaging methods missed it 83% of the time, demonstrating high accuracy with a positive predictive value of about 96.2%. Another study involving over 600 men showed that the scan correctly identified cancerous areas 84% to 92% of the time. In this trial, participants in one arm will receive the 68Ga-PSMA-11 PET/CT scan, a powerful tool for planning further treatment in prostate cancer cases. ^{5 6 7 8 9}

Who Is on the Research Team?

Jeremie Calais

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer recurrence post-surgery, who are willing to undergo radiotherapy. They must have a PSA level of at least 0.1 ng/ml and agree that their treatment plan may include findings from the PET/CT scan. Men currently on hormone therapy or with inflammatory bowel disease, extra-pelvic metastasis, or using other investigational drugs can't participate.

Inclusion Criteria

My prostate cancer diagnosis was confirmed through tissue examination.

I am scheduled for radiation therapy after prostate surgery due to cancer recurrence.

Prostate-specific antigen (PSA) >= 0.1 ng/ml at time of enrollment

Exclusion Criteria

I cannot undergo radiotherapy due to certain health conditions like active inflammatory bowel disease.

Concurrent systemic therapy for prostate cancer with investigational agents

My cancer has spread beyond the pelvic area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants receive 68Ga-PSMA-11 intravenously and undergo whole-body PET/CT

1 day

1 visit (in-person)

Treatment

Participants undergo salvage radiation therapy (SRT) based on PET/CT results

6-8 weeks

Follow-up

Participants are monitored for biochemical progression-free survival and other outcomes

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Gallium Ga 68-labeled PSMA-11

Trial Overview The study tests if a diagnostic procedure using Gallium Ga 68-labeled PSMA-11 (a substance taken up by cancer cells) combined with PET/CT scans can help in planning salvage radiation therapy for recurrent prostate cancer after surgery.

How Is the Trial Designed?

Group I: Arm II (68Ga-PSMA-11 PET/CT) Experimental Treatment 3 Interventions

Participants receive 68Ga-PSMA-11 IV and 50-100 minutes later undergo whole-body (skull base to mid-thighs) PET/CT. Participants then undergo SRT per the discretion of the treating radiation oncologist.

Group II: Arm I (standard of care) Active Control 1 Intervention

Participants receive standard of care SRT.

Gallium Ga 68-labeled PSMA-11 is already approved in United States, European Union for the following indications:

Approved in United States as 68Ga-PSMA-11 for:

• Prostate cancer
• Other cancers expressing PSMA

Approved in European Union as 68Ga-PSMA-11 for:

• Prostate cancer
• Other cancers expressing PSMA

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Ga-PSMA-11 is a promising PET tracer for imaging advanced prostate cancer, showing specific uptake patterns in various organs, which helps in understanding its biodistribution and potential physiological variants.

The study identified normal uptake in the prostate and other organs, as well as benign lesions, which is crucial for avoiding misinterpretations during scans and ensuring accurate diagnosis in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Normal distribution pattern and physiological variants of 68Ga-PSMA-11 PET/CT imaging. Demirci, E., Sahin, OE., Ocak, M., et al.[2022]

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]

[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]

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]

In a study of 19 prostate cancer patients, 68Ga-PSMA PET/CT imaging successfully identified recurrence in 15 out of 17 patients with biochemical recurrence after radical prostatectomy, demonstrating its effectiveness in early detection of cancer spread.

The imaging technique revealed positive sites of recurrence in both single and multiple locations, leading to salvage lymphadenectomy in four patients, with histological confirmation of malignancy in three cases, highlighting its potential to guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic performance of 68GA-PSMA PET/CTin patients with prostate cancer]. Veliev, EI., Tomilov, AA., Goncharuk, DA., et al.[2019]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30350010/

68Ga-PSMA-11 PET/CT in recurrent prostate cancer When 68Ga-PSMA-11 PET/CT was positive, correlative imaging resulted negative in 83% of cases (108/130). 3) The calculated PPV was 96.2%. Conclusion: Our data ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02940262

NCT02940262 | Gallium Ga 68-labeled PSMA-11 PET/CT ... This clinical trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/63/2/240

Diagnostic Performance and Clinical Impact of 68 Ga-PSMA ... Diagnostic performance of 68Ga-PSMA-11 (HBED-CC) PET/CT in patients with recurrent prostate cancer: evaluation in 1007 patients. Eur J Nucl Med ...

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2729065

Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing ... Findings In this prospective single-arm trial of 635 men, 68Ga-PSMA-11 PET demonstrated 84% to 92% positive predictive value at 75% overall ...

5. nature.com nature.com/articles/s41391-023-00755-2

Comparison of 18 F-based PSMA radiotracers with [ 68 Ga ... This study aims to investigate whether Fluorine-18 ( 18 F)-labelled PSMA PET/CT is significantly different from Gallium-68 ( 68 Ga) in primary diagnosis and/or ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02940262

NCT02940262 | Gallium Ga 68-labeled PSMA-11 PET/CT ... This clinical trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8401928/

[68Ga]Ga-PSMA-11: The First FDA-Approved 68Ga ... In numerous partly multicentric retrospective studies, [68Ga]Ga-PSMA-11 PET imaging has significantly improved the detection of recurrent prostate cancer as ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/212642s000lbl.pdf

Gallium Ga 68 PSMA-11 Injection, for intravenous use The safety and efficacy of Ga 68 PSMA-11 Injection were established in two prospective, open-label studies (PSMA-PreRP and PSMA-BCR) in men with prostate cancer ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04216134

Study Details | 68Ga-PSMA-11 PET for the Diagnosis of ... PRIMARY OBJECTIVE: I. To provide clinical access to and assess the safety of the investigational agent Gallium Ga 68-labeled prostate specific membrane antigen ...