What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including those guided by PSMA PET/CT imaging, often involve radiotherapy, surgery, and systemic therapies such as androgen deprivation therapy (ADT) and radioligand therapy. Radiotherapy and surgery can lead to side effects like urinary incontinence, erectile dysfunction, and bowel issues. ADT may cause hot flashes, reduced libido, fatigue, and osteoporosis. Radioligand therapy, such as lutetium Lu 177 vipivotide tetraxetan, can result in myelosuppression, nephrotoxicity, and salivary gland toxicity. These side effects vary in severity and frequency, and patients should discuss them with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that are relevant to the PSMA PET/CT trial. Lutetium Lu 177 vipivotide tetraxetan, a PSMA-targeted radioligand therapy, has been approved for patients with PSMA-positive metastatic castration-resistant prostate cancer (CRPC) who have previously been treated with androgen-receptor pathway inhibitors and taxane-based chemotherapy. Additionally, enzalutamide and abiraterone are FDA-approved for metastatic CRPC, with enzalutamide also approved for nonmetastatic CRPC. These treatments, along with advanced imaging techniques like PSMA PET/CT, aim to improve targeting and management of prostate cancer.

What other types of research exist?

Promising novel alternatives to PSMA PET/CT for prostate cancer patients include PET/MRI using prostate-specific radiotracers, which combines the high sensitivity of PET with the superior soft tissue contrast of MRI. This method has shown high detection rates for recurrent prostate cancer even at low PSA levels. Additionally, molecular biomarkers and genomic classifiers like the Oncotype DX Genomic Prostate Score (GPS) and Decipher Genomic Classifier (GC) are emerging tools that can help guide treatment decisions by providing detailed prognostic information from prostate tissue samples.

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Diagnostic Test

PSMA PET/CT for Advanced Prostate Cancer (PATRON Trial)

Phase 3

Waitlist Available

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

High risk of regional or distant metastases as defined by any of: Newly diagnosed and untreated prostate cancer with CAPRA score 6-10, or stage cN1.

Must not have

Prior curative intent treatment for prostate cancer with local therapy other than surgery (primary radiotherapy or ablative therapies)

Evidence of metastatic disease (M1b bone, M1c viscera/soft tissue) on conventional imaging (if performed)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical risks associated with increased radiation exposure from intensified radiotherapy, surgical complications if procedures are escalated, and general risks linked to systemic therapies for those found with widespread disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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I have prostate cancer and am planning to undergo surgery or radiotherapy.

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I have been newly diagnosed with high-risk prostate cancer.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My cancer has spread to my bones or organs.

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My scans show cancer spread to lymph nodes outside the pelvis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental - PSMAiTxExperimental Treatment1 Intervention

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

Group II: Control - SOC TreatmentActive Control1 Intervention

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments often involve radiotherapy, surgery, and systemic therapies like androgen deprivation therapy (ADT). Radiotherapy uses high-energy radiation to target and kill cancer cells, while surgery, such as radical prostatectomy, involves the removal of the prostate gland and surrounding tissues. ADT works by reducing the levels of androgens (male hormones) that can stimulate the growth of prostate cancer cells. The integration of PSMA PET/CT imaging enhances these treatments by providing more precise localization of cancerous tissues, allowing for better targeting and potentially improving outcomes. This matters for prostate cancer patients as it can lead to more effective treatment plans, reduced side effects, and improved quality of life.

Effect of 18F-DCFPyL PET/CT on the Management of Patients with Recurrent Prostate Cancer: Results of a Prospective Multicenter Registry Trial.Considerations on Integrating Prostate-Specific Membrane Antigen Positron Emission Tomography Imaging Into Clinical Prostate Cancer Trials by National Clinical Trials Network Cooperative Groups.