Androgen Deprivation Therapy for Prostate Cancer
((RANGER) Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach for treating prostate cancer that returns after surgery. All participants first receive targeted radiotherapy to a specific area, and their response is checked after five weeks. Those who respond well are observed, while those who do not receive additional treatment, including pelvic radiotherapy and hormone therapy (also known as Androgen Deprivation Therapy, or ADT). The goal is to determine if this method is as effective as past treatments. Men who have had prostate cancer surgery and have rising PSA levels (a blood marker for prostate cancer) might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial requires a 30-day period without androgen deprivation therapy (ADT) or anti-androgen therapy (AAT) if previously taken for a short duration. Testosterone replacement therapy (TRT) must be stopped, and certain health conditions may require medication adjustments. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that prostate fossa radiotherapy is generally safe for patients. In previous studies, patients who received this treatment did not experience severe gut or urinary side effects, which are common concerns with such treatments. About 15% of patients had late side effects, which were considered manageable.
For those who do not respond well to the initial treatment, pelvic nodal radiotherapy may be used. Studies have found that this type of radiotherapy is also well-tolerated, with no major reports of severe gut or urinary problems.
If necessary, androgen deprivation therapy (ADT) might be used. ADT can pose some risks, especially for the heart, but doctors usually monitor and manage these risks. Overall, the treatments in this trial have been studied, and existing evidence suggests they are generally safe with manageable side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the prostate fossa radiotherapy treatment because it leverages a cutting-edge stereotactic ultra-hypofractionated dosing method, which can deliver high doses of radiation precisely over a short period of 2-4 weeks. Unlike traditional prostate cancer treatments that often require longer durations and may involve more extensive radiotherapy, this approach aims to minimize treatment time while maintaining effectiveness. Moreover, the treatment is adaptive—using the Ethos™ online platform, it can adjust based on a patient’s PSA response, potentially reducing unnecessary exposure to radiation and additional therapies for those who respond well initially. This adaptability and precision could lead to fewer side effects and a more personalized treatment plan for prostate cancer patients.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
Research has shown that prostate fossa radiotherapy, which all participants in this trial will initially receive, effectively treats men with prostate cancer. Studies have found that undetectable PSA (prostate-specific antigen) levels after this treatment suggest a better chance of halting cancer progression. In this trial, participants who do not respond to the initial treatment will receive additional pelvic nodal radiotherapy and hormone therapy (ADT), which can greatly improve survival. ADT, using medications like leuprolide or goserelin, lowers testosterone levels, slowing the growth of prostate cancer. Together, these treatments offer promising ways to manage prostate cancer effectively.56789
Who Is on the Research Team?
Aurelie Garant, MD
Principal Investigator
University of Texas Southwestern Medical Center
Are You a Good Fit for This Trial?
Men aged 18+ who've had prostate cancer treated with surgery in the last 10 years, have a PSA of ≥0.05ng/mL post-op, and no nodal involvement. They must be relatively healthy (ECOG 0-2), use contraception if sexually active, and agree to study terms.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive prostate fossa radiotherapy using stereotactic ultra-hypofractionated dosing (32.5 Gy in 5 fractions over 2-4 weeks)
Response Assessment
Biochemical response is assessed at 5 weeks post-treatment initiation to determine further treatment steps
Observation or Additional Treatment
Responders undergo observation; non-responders receive pelvic nodal radiotherapy and 4 months of androgen deprivation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including regular assessments of PSA levels and patient-reported outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Androgen Deprivation Therapy (ADT)
- Pelvic nodal Radiotherapy
- Prostate Fossa Radiotherapy
Trial Overview
The trial tests initial radiotherapy to the prostate area followed by an assessment at 5 weeks. Non-responders get additional pelvic radiotherapy plus four months of hormone therapy (ADT). The goal is to see if this adaptive method works as well as standard treatments.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
All participants initially receive prostate fossa radiotherapy (RT) using stereotactic ultra-hypofractionated dosing (32.5 Gy in 5 fractions over 2-4 weeks) delivered via the Ethos™ online adaptive platform. At approximately 5 weeks post-RT initiation, PSA response is assessed: * Responders: Patients with PSA \<0.05 ng/mL or a decrease of ≥0.2 ng/mL compared to pre-RT PSA will undergo observation without further immediate therapy. * Non-Responders: Patients not meeting response criteria will receive sequential pelvic nodal RT (25 Gy in 5 fractions over ≤4 weeks) plus androgen deprivation therapy (ADT) for 4 months. Pelvic nodal RT begins within 14 days after response assessment. ADT (GnRH agonists/antagonists, e.g., leuprolide, goserelin, degarelix) will be started before or within 14 days of pelvic nodal RT initiation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
Citations
relugolix, degarelix, and GnRH agonists in the US
This study demonstrates favorable persistence and adherence rates with oral relugolix in patients receiving ADT for advanced prostate cancer.
Oral Relugolix for Androgen-Deprivation Therapy in ...
In this trial involving men with advanced prostate cancer, relugolix achieved rapid, sustained suppression of testosterone levels that was superior to that with ...
Effectiveness and safety of degarelix compared to GnRH ...
Results. Degarelix resulted in a higher frequency of adverse events compared to GnRH agonists (59.7% vs 48.4%; RR: 1.07, 95%CI: 1.02−1.13, p < 0.001).
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journals.lww.com
journals.lww.com/indianjcancer/fulltext/2022/59001/gonadotropin_releasing_hormone_agonists_in.12.aspxGonadotropin-releasing hormone agonists in prostate cancer
When either goserelin or leuprolide was used, the 10-year OS rate was 62%. As an adjuvant to radical prostatectomy, goserelin had a 10-year survival rate of 87% ...
Differential Impact of Gonadotropin-releasing Hormone ...
There was no significant difference in PSA progression, but GnRH antagonist was associated with lower overall mortality rates than GnRH agonists (RR: 0.48, 95% ...
Cardiovascular Safety of Degarelix versus Leuprolide in ...
Reduced cardiorespiratory fitness and increased cardiovascular mortality after prolonged androgen deprivation therapy for prostate cancer. JACC CardioOnc ...
Cardiovascular Outcomes With Degarelix vs Leuprolide as ...
Comparing Cardiovascular Outcomes With Degarelix or Leuprolide as Prostate Cancer Therapy—Applying Real-world Data to Clinical Trial Emulation.
Comparative Cardiovascular Safety of Gonadotropin ...
Real-world evidence studies indicate that degarelix, compared with GnRH agonists, is associated with a modest increased risk of MACEs.
Cardiovascular Effects of GnRH Antagonists Compared ...
Androgen deprivation therapy is the cornerstone of treatment for patients with advanced prostate cancer. Meta-analysis of small, ...
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