A groundbreaking phase III study, URONCOR 06-24, is underway to determine the optimal length of androgen deprivation therapy (ADT) for prostate cancer patients experiencing biochemical recurrence after surgery. This multicenter, randomized trial aims to enhance distant metastasis-free survival by comparing short-term six-month ADT against a longer 24-month regimen when combined with salvage radiotherapy.
Study Design and Participant Allocation
The trial plans to enroll 534 men, who will be randomly assigned to receive either six or twenty-four months of ADT. Participants are categorized based on their risk levels—intermediate or high—and nodal status, distinguishing between those with no lymph node involvement (pN0) and those with uncertain nodal status (pNx). This stratification ensures a balanced comparison between the treatment groups.
Preliminary Enrollment and Treatment Outcomes
As of November 2024, 122 patients have joined the study, with 28% classified as intermediate risk and 72% as high risk. Nearly half of the participants have an uncertain nodal status. The average duration from surgery to biochemical recurrence stands at just over two years, with baseline PSA levels averaging 0.55 ng/ml. Most patients underwent comprehensive restaging, including advanced PSMA PET/CT scans, and a significant proportion received hypofractionated radiotherapy along with elective pelvic irradiation.
Key Insights:
- Balanced distribution of risk factors between treatment arms ensures reliable comparisons.
- High adherence to restaging protocols with the majority utilizing PSMA PET/CT.
- Effective PSA normalization observed across all participants.
- No severe toxicities linked to ADT treatments reported thus far.
Initial findings reveal that all enrolled patients have achieved PSA normalization, and no major adverse effects associated with ADT have been detected. The use of hypofractionation and elective pelvic irradiation appears prevalent, indicating a trend towards tailored radiotherapy approaches in conjunction with ADT.
URONCOR 06-24 stands as the first clinical trial to directly compare the effects of short-term versus long-term ADT in the context of biochemical recurrence post-prostatectomy. The early data suggest that both treatment durations are well-tolerated, with promising PSA outcomes and manageable safety profiles. These results could significantly influence future treatment protocols, offering evidence-based guidance on ADT duration to optimize patient outcomes.
This study not only underscores the importance of personalized treatment strategies based on risk stratification but also paves the way for further research into minimizing treatment-related toxicity while maximizing therapeutic efficacy. Healthcare providers may soon have more concrete data to tailor ADT durations, potentially enhancing the quality of life and survival rates for prostate cancer survivors.
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