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Radiation Therapy

Early vs Delayed Salvage Radiotherapy for Prostate Cancer (TOPP Trial)

Phase 2

Recruiting

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

ECOG 0 or 1

Age ≥ 18 years

Must not have

Previous pelvic radiotherapy

Active or post prostatectomy androgen deprivation use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it's better to give radiation treatment right away or wait and see for men with early prostate cancer.

Who is the study for?

Men over 18 with prostate cancer who've had surgery (prostatectomy) and have a specific low PSA level indicating early recurrence, but no signs of cancer spread on advanced imaging. They must be in good physical condition and understand the study's risks.

What is being tested?

The trial is testing two approaches after surgery: immediate radiotherapy or monitoring PSA levels closely and only using radiotherapy if PSA rises to a certain point. Patients are randomly assigned to one of these strategies.

What are the potential side effects?

Side effects from salvage radiotherapy may include urinary issues, bowel problems, fatigue, sexual dysfunction, and skin irritation in the treated area.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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I am 18 years old or older.

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My cancer is in the early or locally advanced stage but hasn't spread to distant organs.

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My PSMA PET/CT scan was negative after prostate surgery.

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I am scheduled for radiation therapy to my prostate area and maybe lymph nodes.

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My prostate cancer has been confirmed through a biopsy.

Exclusion Criteria

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

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I have had radiation therapy to my pelvic area before.

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I am currently using or have used hormone therapy after prostate surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 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

Surveillance with delayed PSMA PET scan

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: SurveillanceExperimental Treatment1 Intervention

Patients with early biochemical relapse of prostate cancer following radical prostatectomy who have a PSA greater than or equal to 0.1 to less than 0.3 ng/mL with negative PSMA PET/CT will go on surveillance. Routine PSA will be conducted and a repeat PSMA PET/CT imaging will be conducted when the PSA rises to greater than 0.5 to less than 1.0 ng/mL.

Group II: Salvage radiotherapyActive Control1 Intervention

Patients with early biochemical relapse of prostate cancer following radical prostatectomy who have a PSA of greater than or equal to 0.1 to less than 0.3 ng/mL with negative PSMA PET/CT will receive salvage radiotherapy to the prostate bed. This radiotherapy may or may not include the pelvic lymph nodes.

0 / 8Eligibility criteria met