PSMA-11 PET/CT Imaging for Recurrent Prostate Cancer

(PSMA SRT Trial)

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

193 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase III trial studies how well Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT) works in diagnosing participants with prostate cancer that has come back after surgery. 68Ga-PSMA-11 are taken up by cancer cells. Diagnostic procedures, such as PET/CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread. Giving 68Ga-PSMA-11 with PET/CT may help doctors plan better for salvage radiation therapy in participants with recurrent prostate cancer.

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 data supports the effectiveness of the treatment Gallium Ga 68-labeled PSMA-11 for recurrent prostate cancer?

Research shows that Gallium Ga 68-labeled PSMA-11 is effective in detecting recurrent prostate cancer, especially when other imaging methods like 18F-fluorocholine PET/CT are not helpful. It has been shown to improve patient management and outcomes by accurately identifying cancer recurrence. ^{1 2 3 4 5}

Is 68Ga-PSMA-11 safe for use in humans?

68Ga-PSMA-11 has been shown to be generally safe in humans, with no serious adverse events reported in studies. Some minor side effects like itching and rash at the injection site have been noted, but they did not lead to anyone leaving the study. ^{2 6 7 8 9}

How is the treatment 68Ga-PSMA-11 PET/CT unique for recurrent prostate cancer?

68Ga-PSMA-11 PET/CT is unique because it uses a special imaging technique to detect prostate cancer relapses and metastases with high accuracy, especially when other imaging methods like 18F-fluorocholine PET/CT are not effective. This makes it a valuable tool for guiding treatment decisions in patients with recurrent prostate cancer. ^{1 2 9 10 11}

Research Team

Jeremie Calais

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

[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]

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]

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 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 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 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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[PET/CT and biochemical recurrence of prostate adenocarcinoma: Added value of 68Ga-PSMA-11 when 18F-fluorocholine is non-contributive]. [2019]

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

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

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

Clinical impact of 68Ga-PSMA-11 PET on patient management and outcome, including all patients referred for an increase in PSA level during the first year after its clinical introduction. [2021]

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

Performance of [68Ga]Ga-PSMA-11 PET/CT in patients with recurrent prostate cancer after prostatectomy-a multi-centre evaluation of 2533 patients. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 PET/CT in recurrent hormone-sensitive prostate cancer (HSPC): a prospective single-centre study in patients eligible for salvage therapy. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Normal distribution pattern and physiological variants of 68Ga-PSMA-11 PET/CT imaging. [2022]

7. 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]

8. 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]

9. 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]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Diagnostic performance of 68GA-PSMA PET/CTin patients with prostate cancer]. [2019]

11. Austria pubmed.ncbi.nlm.nih.gov

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