PSMA-Guided Salvage Radiation for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method of using salvage radiation, guided by special scans, to treat prostate cancer that has returned after surgery. The goal is to reduce side effects while effectively controlling the cancer. Men who have undergone prostate surgery and now show rising PSA levels (indicating a possible return of cancer) may be suitable candidates. Participants will receive targeted radiation based on their scan results. The trial will evaluate how well this approach controls cancer and what side effects occur. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications. However, all participants will receive standard androgen deprivation therapy (a treatment to lower male hormones) for 6-24 months, which may affect your current treatment plan.
What prior data suggests that this PSMA-guided salvage radiation is safe for prostate cancer patients?
Research has shown that PSMA-guided salvage radiation is generally easy for patients to handle. Studies indicate that using PSMA-PET scans to guide radiation helps target cancer more accurately. This method may lower the chance of cancer recurrence and improve survival without the cancer spreading.
Regarding safety, the treatment reduces radiation exposure to healthy tissues. This targeted approach can lead to fewer side effects. However, like any radiation therapy, some side effects may occur, such as tiredness, skin reactions, or urinary and bowel issues. Importantly, studies did not find any unexpected or severe side effects specifically linked to the PSMA-guided method.
Overall, evidence suggests that PSMA-guided salvage radiation is a safe option for treating prostate cancer after surgery. It offers a promising balance between effective cancer control and manageable side effects.12345Why are researchers excited about this trial's treatment?
Researchers are excited about PSMA-guided salvage radiation for prostate cancer because it offers a more precise targeting method for radiation therapy. Unlike traditional approaches that might irradiate broader areas, this method uses advanced imaging techniques like MRI and PSMA-PET/CT scans to pinpoint exactly where the cancer cells are. This precise targeting can potentially reduce damage to healthy tissue and improve treatment outcomes. Additionally, by delivering a higher radiation dose specifically to areas identified by imaging, there's a possibility of more effectively eradicating cancer cells, which could lead to better long-term control of the disease.
What evidence suggests that PSMA-guided salvage radiation might be an effective treatment for prostate cancer?
Research has shown that PSMA-guided salvage radiation, which participants in this trial will receive, effectively treats prostate cancer. In one study, 64% of patients who received this treatment did not experience a return of cancer over five years. This indicates that for 64% of these patients, the cancer remained absent for at least five years. Other studies have found that using PSMA PET scans to guide radiation can lead to better outcomes, such as preventing the cancer from spreading and delaying its return. This technique allows doctors to aim the treatment more accurately, potentially enhancing its effectiveness. Overall, strong evidence supports using this method for treating prostate cancer after surgery.12345
Who Is on the Research Team?
Michael Baine, PhD/MD
Principal Investigator
University of Nebraska
Are You a Good Fit for This Trial?
This trial is for adult men over 30 years old who've had prostate cancer surgery but still have rising PSA levels, indicating potential cancer recurrence. They must be healthy enough for radiation therapy and have a life expectancy of more than 5 years. Men with distant metastatic disease, conditions that prevent radiation treatment, or inability to follow the study protocol cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive external beam radiation therapy with daily image guidance, followed by a sequential boost to PSMA/MRI-defined disease. Standard-of-care androgen deprivation therapy (ADT) is administered for 6-24 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with phone toxicity check 1 month post-RT, clinic visits at 4 months post-RT, then every 3 months until 24 months after completion of ADT.
What Are the Treatments Tested in This Trial?
Interventions
- Salvage Radiation
Trial Overview
The study tests if PSMA-PET/MRI-guided salvage radiation can reduce severe side effects while controlling recurrent prostate cancer after surgery. It involves external beam radiation with daily image guidance and optional androgen deprivation therapy (ADT). The main goal is to see if this approach leads to fewer acute toxicities compared to historical data.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Enrolled patients will receive an MRI and PSMA-PET/CT scan to identify locations of disease. The intervention will involve salvage radiation therapy to the prostate bed, pelvis, and pelvic nodes as indicated by imaging. External beam radiation therapy will consist of 45 Gy delivered in 25 daily fractions, followed by a sequential boost to PET-avid disease to 63-70.2 Gy in an additional 10-14 fractions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Nebraska
Lead Sponsor
Citations
Long-term outcomes of PSMA PET/CT-guided radiotherapy ...
Our results demonstrate that [⁶⁸Ga]Ga-PSMA PET/CT-guided sRT is an effective treatment option for these patients, with a 5-year bRFS of 64%.
Prostate-Specific Membrane Antigen PET-Guided ...
Recent studies have reported an advantage in both metastasis-free and biochemical relapse–free survival in adopting early salvage radiation ...
Better Oncological Outcomes After Prostate-specific ...
Our results suggest a moderate improvement in short-term BRFS if PSMA PET is used to guide sRT. One possible reason is individualized PLN coverage facilitated ...
PSMA-PET Guided De-escalation of Salvage Radiation ...
Purpose: Prospective, single-site Phase II study testing whether PSMA-PET/MRI-guided, de-escalated salvage radiation reduces acute Grade ≥2 ...
a retrospective multicenter cohort study using PSMA-PET ...
PSMA-PET improves risk stratification in salvage radiotherapy for prostate cancer. •. Pre-SRT PSA < 0.2 ng/mL and PSMA-PET negativity predict ...
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