Early vs Delayed Salvage Radiotherapy for Prostate Cancer
(TOPP Trial)
Trial Summary
What is the purpose of this trial?
The investigators will randomize patients presenting with early BCR with a negative baseline PSMA PET/CT, to upfront SRT or surveillance. Early BCR is defined as a PSA relapse of \>0.1 to \<0.3 ng/mL. Patients in the surveillance arm will be monitored with PSA every 3 months. A repeat PSMA PET/CT will be undertaken when the PSA reaches a target level of \>0.5 to \<1.0 ng/mL. Both early radiation treatment and surveillance with repeat PSMA PET/CT imaging are within patterns of practice locally; therefore, the investigators believe that there is clinical equipoise on this subject.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using androgen deprivation therapy, you cannot participate in the trial.
What data supports the effectiveness of the treatment Salvage Radiotherapy for Prostate Cancer?
Research shows that salvage radiotherapy (SRT) can improve survival in prostate cancer patients who experience a rise in PSA (a protein that can indicate cancer activity) after surgery, without evidence of cancer spread. This approach may reduce side effects compared to immediate radiation after surgery, as it targets only those with signs of cancer returning.12345
Is salvage radiotherapy generally safe for humans?
Salvage radiotherapy (SRT) for prostate cancer has been studied for safety, showing some patients experience urinary and gastrointestinal side effects. In one study, 9% of patients had severe urinary issues, and 7% had moderate gastrointestinal issues, but severe gastrointestinal problems were rare.24678
How is salvage radiotherapy different from other treatments for prostate cancer?
Salvage radiotherapy (SRT) is unique because it is specifically used after prostate surgery (radical prostatectomy) to target any remaining cancer cells when prostate-specific antigen (PSA) levels rise, indicating a recurrence. Unlike initial treatments, SRT is applied when cancer returns, and its timing (early vs delayed) can impact its effectiveness.29101112
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either early salvage radiotherapy or surveillance with delayed PSMA PET/CT imaging
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Salvage radiotherapy
Salvage radiotherapy is already approved in United States, European Union, Canada for the following indications:
- Prostate cancer recurrence after prostatectomy
- Prostate cancer recurrence after prostatectomy
- Prostate cancer recurrence after prostatectomy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor