PSMA PET/CT for Advanced Prostate Cancer

(PATRON Trial)

Recruiting at 19 trial locations

Overseen By Dounia Kellou

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Androgen deprivation therapy

Disqualifiers: High comorbidity index, Metastatic 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

Compensation: Varies

Number of Visits: 1

Duration: 6-8 weeks

800 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if a special imaging scan can help doctors give better-targeted and stronger treatments for high-risk prostate cancer patients. The scan highlights cancer cells, guiding more precise treatments. The goal is to improve patient outcomes and quality of life. This new imaging method has revolutionized prostate cancer detection, making it a promising tool for evaluating patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy, you must have stopped it at least 12 months before joining the trial.

What data supports the effectiveness of the treatment PSMA PET/CT guided intensification of therapy for advanced prostate cancer?

PSMA PET/CT scans have shown to improve the detection of prostate cancer and guide treatment decisions, leading to a high number of changes in management. Studies suggest that using PSMA PET/CT to guide radiotherapy can improve outcomes, such as biochemical recurrence-free survival, and reduce treatment progression in many patients. ^{1 2 3 4 5}

Is PSMA PET/CT safe for use in humans?

Research on PSMA PET/CT, particularly in prostate cancer, shows it has an acceptable safety profile with no severe side effects reported in the studies. Some patients experienced mild temporary side effects, but overall, it appears to be safe for human use. ^{5 6 7 8 9}

How is PSMA PET/CT guided intensification of therapy different from other treatments for advanced prostate cancer?

PSMA PET/CT guided intensification of therapy is unique because it uses advanced imaging to precisely target prostate cancer, allowing for more accurate staging and treatment planning compared to conventional methods. This approach can lead to significant changes in management and potentially improve outcomes by tailoring radiotherapy or surgery to the specific needs of the patient. ^{1 4 5 10 11}

Eligibility Criteria

Men over 18 with high-risk prostate cancer who are planned for curative radiotherapy or surgery, or have had a prostatectomy and now show signs of cancer return. They should not have received other local treatments, be relatively fit (ECOG ≤ 2), and not on recent hormone therapy.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

My prostate cancer is at high risk of spreading and either untreated or has a CAPRA score of 6-10.

I had prostate surgery and my PSA levels are now above 0.1ng/mL.

Exclusion Criteria

I stopped hormone therapy for cancer less than a year ago.

I had treatments like radiotherapy for prostate cancer, not surgery.

My cancer has spread to my bones or organs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PSMA PET/CT imaging to guide treatment intensification

1 week

1 visit (in-person)

Treatment

Participants receive intensified radiotherapy or surgery based on PSMA PET/CT findings

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Control Arm
• PSMA PET/CT guided intensification of therapy

Trial Overview The trial is testing if using PSMA PET/CT scans to guide more intense treatment improves outcomes in advanced prostate cancer patients compared to standard imaging methods. Participants will either receive intensified therapy based on the scan results or follow conventional treatment protocols.

Participant Groups

Group I: Experimental - PSMAiTx Experimental Treatment 1 Intervention

Participants undergo PSMA PET/CT prior to treatment, and treated intensified based on image findings.

Group II: Control - SOC Treatment Active Control 1 Intervention

Participants to receive surgery or radiotherapy (+/- hormone therapy) as planned per SOC.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Kingston Health Sciences Centre

Collaborator

Trials

32

Recruited

34,400+

Queen's University

Collaborator

Kingston Health Sciences Centre

Collaborator

Trials

312

Recruited

112,000+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

Lantheus Medical Imaging

Industry Sponsor

Trials

57

Recruited

4,333,000+

British Columbia Cancer Agency

Collaborator

Trials

181

Recruited

95,900+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+

Tom Baker Cancer Centre

Collaborator

Trials

30

Recruited

8,900+

Findings from Research

In a prospective cohort study of men with biopsy-proven prostate cancer, 80% did not experience treatment progression after receiving treatment plans based on PSMA PET-CT results over a follow-up period of 29 months.

Men with distant nodes identified on PSMA PET-CT scans had a significantly higher risk (5 times) of treatment progression, highlighting the importance of these scans in assessing disease severity and guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distant Nodes Seen on PSMA PET-CT Staging Predicts Post-Treatment Progression in Men with Newly Diagnosed Prostate Cancer-A Prospective Cohort Study. Ong, S., Pascoe, C., Kelly, BD., et al.[2022]

In a phase 2 trial involving 253 men with prostate cancer, PSMA-PET/CT significantly intensified radiation therapy (RT) in over half of the patients, indicating its potential to enhance treatment effectiveness.

New lesions were detected in a substantial percentage of patients, particularly in those with oligometastatic (45.5%) and salvage post-prostatectomy (51.6%) conditions, while the treatment was associated with minimal severe side effects (2.5% experienced grade 3+ events).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PSMA-PET/CT-Guided Intensification of Radiation Therapy for Prostate Cancer (PSMAgRT): Findings of Detection Rate, Effect on Cancer Management, and Early Toxicity From a Phase 2 Randomized Controlled Trial. Petit, C., Delouya, G., Taussky, D., et al.[2023]

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]

In a study of 19 patients with prostate cancer recurrences, 68Ga-PSMA-PET/CT-directed stereotactic body radiotherapy (SBRT) showed an 80.8% one-year PSA control rate, indicating its efficacy in managing oligometastases after surgery.

The treatment had a favorable safety profile, with no severe acute toxicity (G3+) reported, and only one case of temporary late G3-proctitis, suggesting that this approach is both effective and safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-PET/CT-directed IGRT/SBRT for oligometastases of recurrent prostate cancer after initial surgery. Marzec, J., Becker, J., Paulsen, F., et al.[2021]

PSMA-targeted PET/CT is a highly sensitive and specific imaging technique that significantly improves the detection and management of recurrent prostate cancer compared to conventional imaging methods.

This advanced imaging allows for better patient selection for localized salvage therapies and has shown promise in delaying the need for systemic treatments in patients with oligometastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate-specific membrane antigen targeted PET/CT for recurrent prostate cancer: a clinician's guide. Young, S., Liu, W., Zukotynski, K., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

PSMA PET/CT guided intensification of therapy in patients at risk of advanced prostate cancer (PATRON): a pragmatic phase III randomized controlled trial. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Distant Nodes Seen on PSMA PET-CT Staging Predicts Post-Treatment Progression in Men with Newly Diagnosed Prostate Cancer-A Prospective Cohort Study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

PSMA PET-CT in the Diagnosis and Staging of Prostate Cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Outcome after PSMA PET/CT based radiotherapy in patients with biochemical persistence or recurrence after radical prostatectomy. [2021]

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

PSMA-PET/CT-Guided Intensification of Radiation Therapy for Prostate Cancer (PSMAgRT): Findings of Detection Rate, Effect on Cancer Management, and Early Toxicity From a Phase 2 Randomized Controlled Trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Can PSMA PET/CT help in dose-tailoring in post-prostatectomy radiotherapy? [2023]

7. 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]

8. Canada pubmed.ncbi.nlm.nih.gov

Canadian Urological Association best practice report: Prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) and PET/magnetic resonance (MR) in prostate cancer. [2022]

9. England pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-PET/CT-directed IGRT/SBRT for oligometastases of recurrent prostate cancer after initial surgery. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Prostate-specific membrane antigen targeted PET/CT for recurrent prostate cancer: a clinician's guide. [2022]

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

68Ga-PSMA-11 PET/MRI in Patients with Newly Diagnosed Intermediate- or High-Risk Prostate Adenocarcinoma: PET Findings Correlate with Outcomes After Definitive Treatment. [2023]