Risk-Adapted Treatment for Prostate Cancer
(RISK-ADAPT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach for treating metastatic hormone-sensitive prostate cancer, a type that has spread but still responds to hormone therapy. The researchers aim to determine if a risk-adapted treatment plan can extend the time patients live without cancer progression, while also reducing side effects and improving quality of life. The trial includes two groups: one for low-risk patients and another for high-risk patients, each receiving a different combination of therapies, including Androgen Deprivation Therapy (ADT), Androgen Receptor Pathway Inhibitor (ARPI), and Docetaxel (a chemotherapy drug). Men with prostate cancer that has spread and who have previously received hormone therapy but not chemotherapy may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in prostate cancer care.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found that Androgen Deprivation Therapy (ADT) can cause side effects, such as sexual problems and changes in physical appearance. However, it also improved survival rates for prostate cancer patients. Researchers have extensively studied Androgen Receptor Pathway Inhibitors (ARPI), which generally offer significant survival benefits, though they may increase the risk of bone fractures. Docetaxel, another treatment in the trial, significantly reduced deaths specifically from prostate cancer and is usually well-tolerated, even in older patients. Together, these treatments have been well-studied, and while they have side effects, they are generally considered safe and effective for treating prostate cancer.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the risk-adapted treatment approach for prostate cancer because it tailors therapy intensity based on the patient's risk level. For low-risk prostate cancer patients, this strategy combines Androgen Deprivation Therapy (ADT), Androgen Receptor Pathway Inhibitors (ARPI), and radiation, with the option to continue or pause treatment based on specific PSA levels, allowing for personalized care. For high-risk patients, the addition of docetaxel to the regimen potentially enhances effectiveness by addressing aggressive cancer cells more comprehensively. Unlike traditional treatments that often apply a one-size-fits-all approach, this trial's adaptability to patient risk and response could optimize outcomes and minimize unnecessary exposure to extensive therapies.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
Research has shown that combining hormone therapy with drugs that block hormone signals significantly improves survival for patients with prostate cancer that has spread and still responds to hormones. Specifically, this combination can extend life by 18-24 months compared to hormone therapy alone. In this trial, low-risk prostate cancer patients will receive a combination of Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI), along with prostate radiation.
For high-risk prostate cancer patients, the trial includes a triplet therapy with ADT, ARPI, and the chemotherapy drug docetaxel. Studies have found that adding docetaxel to this combination further increases survival rates by about 25% for patients with a large amount of cancer. Early drops in prostate-specific antigen (PSA) levels, which indicate cancer progression, have strongly signaled good results with these treatments. Overall, these treatments not only help patients live longer but also improve quality of life by slowing disease progression.678910Who Is on the Research Team?
Paul D Leger, MD
Principal Investigator
Georgetown University
Are You a Good Fit for This Trial?
This trial is for adults with metastatic hormone-sensitive prostate cancer who are eligible for standard treatments. Patients must be able to give consent and follow the treatment plan. Prior short-term use (up to 8 weeks) of certain therapies is allowed, but not prior docetaxel in low-risk patients.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Low risk patients receive 6-month doublet therapy with ADT + ARPI + prostate radiation, followed by 30 months ARPI monotherapy. High-risk patients receive triplet therapy with ADT + ARPI + 6 cycles of docetaxel, followed by 18-months of ADT + ARPI and then 12-month ARPI monotherapy.
Follow-up
Participants are monitored for radiographic progression-free survival and overall survival, with assessments including quality-of-life and sexual function changes.
Open-label extension (optional)
At 36 months, participants maintaining a PSA ≤ 0.2ng/mL may opt to discontinue treatment with active surveillance or continue ARPI until disease progression or intolerable toxicity.
What Are the Treatments Tested in This Trial?
Interventions
- Androgen Deprivation Therapy (ADT)
- Androgen Receptor Pathway Inhibitor (ARPI)
- Docetaxel
- Prostate Radiation
Trial Overview
The study tests a risk-adapted approach using combinations of hormone therapy (ADT), androgen receptor inhibitors (ARPI), prostate radiation, and possibly chemotherapy (docetaxel). Treatments may be reduced over time based on patient response.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Low risk patients will receive 6-month doublet therapy with Androgen Deprivation Therapy (ADT) + Androgen Receptor Pathway Inhibitor (ARPI) + prostate radiation with or without radiation to metastatic sites followed by 30 months ARPI monotherapy. At a 36-month timepoint, those who maintain a prostate specific antigen (PSA) ≤ 0.2ng/mL will have the option to either discontinue treatment proceeding with active surveillance or continue on their ARPI until disease progression or intolerable toxicity. Patients who discontinue ARPI will resume ARPI and ADT when the PSA ≥ 2 ng/mL above the lowest PSA on two consecutive checks at least 1 month apart, there is evidence of progressive disease (PD) on conventional scans \[CT/MRI imaging per modified RECIST 1.1 or bone scan per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)\], clinical symptoms of progression, or if the patient prefers to continue ARPI and ADT.
High-risk patients will receive triplet therapy with ADT + ARPI + 6 cycles of docetaxel followed by 18-months of ADT + ARPI and then 12-month ARPI monotherapy. If a patient has high-risk disease but, based on the investigator's judgment, has contraindications to docetaxel or is deemed unsuitable for it, they will receive the same treatment regimen as other high-risk patients minus the docetaxel. Then at a 36-month timepoint, those who maintain a PSA ≤ 0.2ng/mL will have the option to either discontinue treatment with active surveillance or continue ARPI until disease progression or intolerable toxicity. Patients who discontinue ARPI will resume ARPI and ADT when the PSA ≥ 2 ng/mL above the lowest PSA (nadir) on two consecutive checks at least 1 month apart, there is evidence of progressive disease (PD) on conventional scans \[CT/MRI imaging per modified RECIST 1.1 or bone scan per PCWG3\], clinical symptoms of progression, or if the patient prefers to continue ARPI and ADT.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Georgetown University
Lead Sponsor
Lantheus Medical Imaging
Industry Sponsor
Citations
Prostate-Specific Antigen Reduction After Androgen ...
In an analysis of data from the TITAN study, 78% of patients treated with apalutamide plus ADT had a deep PSA reduction (defined as ≥90% ...
Comparative effectiveness of androgen receptor pathway ...
This treatment intensification strategy has consistently shown overall survival (OS) improvements of 18–24 months compared with ADT monotherapy, establishing a ...
Survival benefit associated with first-line androgen receptor ...
Conclusions. First-line ADT + ARPI was associated with significantly improved outcomes vs ADT alone in de novo mCSPC. These real-world results ...
4.
targetedonc.com
targetedonc.com/view/considering-the-evolution-of-arpi-combination-therapy-in-mhspcConsidering the Evolution of ARPI Combination Therapy in ...
This trial is for patients with confirmed prostate cancer with or without a first-generation antiandrogen, no prior second-generation ARPI. They ...
Androgen Receptor Pathway Inhibitor Monotherapy in ...
In general, treatment outcomes with ARPIs were comparable with or superior to that of ADT, although not surpassing the efficacy of ARPI + ADT. While changes in ...
Adverse Effects of Androgen Deprivation Therapy for Prostate ...
There is growing evidence that ADT negatively affects men's psychosocial well-being (eg, causing sexual dysfunction, bodily feminization) and physical health.
Balancing Hormone Therapy: Mitigating Adverse Effects of ...
Treatment advances including ADT have led to improvements in PCa management and survival, with trials reporting median survival of over 6 years ...
Androgen-targeted therapy in men with prostate cancer
These findings, together with data that demonstrate improved survival and prolonged time to disease progression with lower levels of T, has led ...
New analysis finds timing androgen-deprivation therapy ...
The authors concluded that ADT sequencing demonstrated a significant impact on clinical outcomes with a strong correlation to RT field size.
Comparison of Short-Term Outcomes and Safety Profiles ...
This study aimed to compare the short-term outcomes and safety profiles of androgen-deprivation therapy (ADT)+abiraterone/prednisone with ...
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