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Virus Therapy

PSMA-PET Guided Radiotherapy for Prostate Cancer (PSMA-PETgRT Trial)

Phase 2 & 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

Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer and CAPRA score 6-10

ECOG 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new type of PET scan is better than the current standard of care for finding cancer metastases, which would then inform more effective radiation treatment.

Who is the study for?

This trial is for men with high-risk localized prostate cancer or those who've had treated prostate cancer but now have rising PSA levels. They should have a small number (≤5) of metastases, be in good physical condition (ECOG 0-1), and not have received certain prior treatments like recent androgen deprivation therapy.

What is being tested?

The study compares two ways to plan radiotherapy: one uses a new type of PET/CT scan that's better at finding where the cancer has spread, while the other uses standard imaging. The goal is to see if using this new scan leads to better treatment outcomes.

What are the potential side effects?

While the document doesn't specify side effects related to PSMA-PET/CT scans, generally, PET scans are considered safe. However, there may be risks associated with radiation exposure and allergic reactions to contrast agents used during imaging.

Eligibility Criteria

Inclusion Criteria

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

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I have high-risk prostate cancer with a CAPRA score between 6-10.

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I am fully active or can carry out light work.

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I have prostate cancer and am scheduled for radiotherapy aimed at curing it.

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I had prostate cancer treated but my PSA levels have since increased.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Failure-free survival

Secondary study objectives

Acute and delayed toxicities

Detection yield of PSMA PET imaging

Health-related quality of life

+2 more

Awards & Highlights

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: PSMA-PETgRTExperimental Treatment1 Intervention

PSMA-PET/CT imaging is performed during treatment planning. Treating physicians are informed of test results and advised to include up to 5 PSMA-PET avid sites distant to the prostate gland, if present, in the radiotherapy treatment plan.

Group II: StandardActive Control1 Intervention

Patient's receive standard care radiotherapy and do not undergo PSMA-PET/CT imaging.

0 / 4Eligibility criteria met