Hormone and Radiation Therapy for Prostate Cancer
(ARPEGGIO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial targets men with intermediate- or high-risk prostate cancer. It seeks to determine if special imaging during hormone therapy (Androgen Deprivation Therapy, or ADT) can help doctors target cancer more precisely with radiation. Participants will receive standard hormone therapy and radiation, along with three imaging scans over six months. Men diagnosed with prostate cancer who have undergone specific MRI and PET scans and have not yet started certain treatments might be suitable candidates. The trial aims to enhance the accuracy of future prostate cancer treatments and reduce side effects. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in prostate cancer care.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must be able to stop anti-coagulation medications for a procedure during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that Androgen Deprivation Therapy (ADT) is generally safe, though it can cause some side effects. One study found that 43% of prostate cancer patients on ADT experienced major sexual problems. Another report noted that longer use of ADT is linked to more side effects in patients under 75. ADT's long history of use indicates it is well-researched.
For Stereotactic Body Radiation Therapy (SBRT), studies indicate it is mostly safe with a few side effects. About 10% of people might have stomach issues, and around 25% could experience some erectile dysfunction. Overall, SBRT has a good track record and is considered effective for treating prostate cancer.
Both treatments have been widely used, providing doctors with a solid understanding of their safety. While side effects are possible, these treatments have been extensively studied.12345Why are researchers excited about this trial?
Researchers are excited about this treatment for prostate cancer because it combines Androgen Deprivation Therapy (ADT) with Stereotactic Body Radiation Therapy (SBRT) and advanced PSMA PET/CT imaging. Unlike traditional treatments that might use standard radiation, SBRT delivers highly focused radiation doses, potentially improving precision and reducing side effects. The use of PSMA PET/CT imaging allows for better tumor visualization, enabling more targeted therapy. This innovative combination aims to enhance treatment effectiveness and offer a more personalized approach to managing prostate cancer.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
Research has shown that Androgen Deprivation Therapy (ADT) effectively controls prostate cancer. One study found that about 59% of men experienced no disease progression five years after receiving ADT. Stereotactic Body Radiation Therapy (SBRT) also shows promising results. Studies indicate that around 95% of men treated with SBRT remained cancer-free after six years. In this trial, participants will receive a combination of ADT, SBRT, and PSMA PET/CT imaging, which have proven effective in treating prostate cancer, making them reliable options for managing the disease.56789
Are You a Good Fit for This Trial?
This trial is for men with intermediate or high-risk prostate cancer who are at least 18 years old, have good performance status, and plan to receive hormone therapy and radiation. They must have had specific MRI and PSMA PET scans showing at least one significant lesion within the past 180 days.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Hormone Therapy
Participants receive androgen deprivation therapy (ADT) for prostate cancer
Radiation Therapy
Participants receive high-precision radiation therapy (SBRT) to the prostate
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Androgen Deprivation Therapy (ADT)
- PSMA PET/CT
- Stereotactic Body Radiation Therapy (SBRT) +/- focal microboost
Trial Overview
The study tests if advanced imaging during hormone therapy can help target radiation more accurately in prostate cancer treatment. Participants will get standard hormone therapy, radiation, plus three special imaging scans over six months to improve future treatments.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
* ADT as prescribed * PSMA PET/CT imaging will be completed at baseline, 8 weeks after ADT start, and at end of treatment * SBRT is administered starting 10 weeks after ADT start
Find a Clinic Near You
Who Is Running the Clinical Trial?
Martin T. King, MD, PhD
Lead Sponsor
Blue Earth Diagnostics
Industry Sponsor
Dana-Farber/Brigham and Women's Cancer Center
Collaborator
Citations
Long‐term outcomes of androgen deprivation therapy in ...
The median follow‐up was 2.33 y (IQR: 1.01‐4.40 y). PFS at 5 y was 59.1% (95% CI: 56.8%‐61.1%) for all super‐elderly men.
Study suggests many men may not need long-term ...
While effective at controlling the disease, long-term ADT can cause side effects, including bone loss, muscle loss and cardiovascular problems. Current ...
Optimal Duration of Androgen Deprivation Therapy With ...
This meta-analysis examines the ideal duration of androgen deprivation therapy for patients with prostate cancer treated with radiotherapy.
Articles Duration of androgen deprivation therapy with ...
Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy.
Significance of androgen‐deprivation therapy for ...
According to the results from several retrospective studies, adding ADT consistently failed to improve survival outcomes among IR PCa ...
Efficacy and safety evaluation of androgen deprivation therapy ...
This systematic review and network meta-analysis aimed to assess the comparative effectiveness and safety profiles of current combination ...
Effect of Androgen Deprivation on Long-term Outcomes ...
The 15-year restricted mean survival time was longer with ADT vs without ADT for patients with UIR (10.5 vs 9.8 years; difference, 0.7 year; 95% ...
Adverse health outcomes for prostate cancer patients ...
Overall, 43% (PCa patients) and 20% (controls) reported major sexual problems. In patients aged < 75 years, longer than short ADT duration ...
Fifteen-Year Survival Outcomes Following Primary Androgen ...
Fifteen-year survival outcomes following primary androgen-deprivation therapy for localized prostate cancer.
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