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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights

TOPP Trial 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.Check my eligibility
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.See study design
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.

TOPP Trial 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.

TOPP Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Surveillance with delayed PSMA PET scan

TOPP 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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,472 Previous Clinical Trials
484,953 Total Patients Enrolled
63 Trials studying Prostate Cancer
15,360 Patients Enrolled for Prostate Cancer

Media Library

Salvage radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05008900 — Phase 2
Prostate Cancer Research Study Groups: Surveillance, Salvage radiotherapy
Prostate Cancer Clinical Trial 2023: Salvage radiotherapy Highlights & Side Effects. Trial Name: NCT05008900 — Phase 2
Salvage radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05008900 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What hazards are associated with Salvage radiotherapy?

"The safety of salvage radiation therapy was rated at a 2 because the current clinical data only supports its safety, not efficacy."

Answered by AI

What is the total expected enrollment for this research endeavor?

"Affirmative, clinicaltrials.gov details that patient recruitment is in progress for this trial which was originally published on March 22nd 2022 and most recently updated April 7th 2022. 40 participants need to be recruited from a single medical centre."

Answered by AI

Is enrollment for this research study still available?

"Affirmative. Clinicaltrials.gov exhibits that this medical investigation is currently seeking participants, which was initially posted on March 22nd 2022 and recently modified on April 7th 2022. 40 volunteers need to be enrolled at a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Timing of Post-prostatectomy PSMA Imaging
2022. "Timing of Post-prostatectomy PSMA Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05008900.
All > Canada Prostate Cancer
~27 spots leftby Sep 2030
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