PSMA PET/CT for Advanced Prostate Cancer

(PATRON Trial)

Not currently recruiting at 20 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve treatments for advanced prostate cancer. It uses a special imaging technique called PSMA PET/CT to help doctors decide whether to intensify treatments like radiotherapy or surgery. The trial aims to determine if this approach leads to better cancer outcomes and fewer side effects compared to regular imaging methods. Men with high-risk prostate cancer, who are planned for treatment like surgery or radiotherapy, or who have had surgery but face a potential recurrence, might be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in prostate cancer treatment.

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 prior data suggests that PSMA PET/CT is safe for guiding treatment in advanced prostate cancer?

Research shows that PSMA PET/CT, a type of scan, helps doctors see prostate cancer more clearly. This scan guides more precise treatments like surgery or radiotherapy. Studies have found that PSMA PET/CT can detect cancer cells that other scans might miss, aiding doctors in treating cancer more effectively.

Regarding safety, earlier research suggests that PSMA PET/CT is generally well-tolerated, with patients usually experiencing no serious side effects. The scan uses a low dose of radiation, similar to CT or X-rays, and is generally considered safe.

In summary, PSMA PET/CT improves how doctors treat prostate cancer and is safe for patients. For those considering joining a trial, this treatment option appears promising based on past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PSMA PET/CT guided therapy for advanced prostate cancer because it offers a more precise way to target cancer cells. Unlike traditional treatments, such as surgery or radiotherapy often combined with hormone therapy, this approach uses advanced imaging to identify the exact locations of cancer spread. This allows doctors to intensify treatment specifically where it is needed the most, potentially improving outcomes while minimizing unnecessary side effects. By offering a tailored treatment plan based on each patient's unique cancer profile, PSMA PET/CT could lead to more personalized and effective care for prostate cancer patients.

What evidence suggests that PSMA PET/CT guided intensification of therapy is effective for advanced prostate cancer?

Research shows that PSMA PET/CT guided therapy, which participants in this trial may receive, can significantly improve treatment outcomes for advanced prostate cancer. Studies indicate that this imaging technique helps doctors plan and enhance radiotherapy or surgery by accurately assessing the cancer's spread. This method has been linked to better cancer control and longer periods without recurrence, allowing patients to live longer without the cancer returning. Additionally, PSMA PET/CT is considered cost-effective, improving outcomes without additional costs. These findings suggest that PSMA PET/CT offers a more accurate and effective treatment option for those with high-risk prostate cancer. Participants in the control arm will receive standard-of-care treatment, which includes surgery or radiotherapy, with or without hormone therapy. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35260100/

PSMA PET/CT guided intensification of therapy in patients ... This study aims to assess the impact of intensified radiotherapy or surgery guided by PSMA PET/CT in patients at risk of advanced prostate cancer.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04557501

Study Details | NCT04557501 | PSMA PET/CT Guided ... Investigators expect to show that PSMA PET/CT will have a direct and profound impact on radiotherapy and surgery practice, translating to improved failure-free ...

3. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-022-09283-z

PSMA PET/CT guided intensification of therapy in patients at ... ... PSMA PET findings improves outcomes of patients at risk of advanced prostate cancer in a manner that is cost-effective. Trial registration.

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2839396

Prostate-Specific Membrane Antigen PET-Guided ... This randomized clinical trial examines the association of prostate-specific membrane antigen positron emission tomography (PET)–guided ...

5. redjournal.org redjournal.org/article/S0360-3016(23)00006-8/abstract

PSMA-PET/CT-Guided Intensification of Radiation ... Primary endpoint was failure-free survival at 5 years, with analysis pending further follow-up. Secondary endpoints included new lesion ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8902723/

PSMA PET/CT guided intensification of therapy in patients at ... This study aims to assess the impact of intensified radiotherapy or surgery guided by PSMA PET/CT in patients at risk of advanced prostate cancer.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12227496/

The Evolving Role of PSMA-PET/CT in Prostate Cancer ... Collectively, these data highlight that PSMA PET/CT enhances survival by enabling earlier detection of micrometastases (30–40% higher ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1053429625000475

PSMA-PET Guided Radiotherapy in Prostate Cancer The synergy between PSMA-PET and radiotherapy enables a more effective therapeutic approach across both early and advanced stages of PCa.