This is a Phase I/II trial evaluating the effectiveness of adding neoadjuvant HDR-B prior to RALP for HR-PCa patients with selective AAB for decipher high risk or pathologically node positive patients. Patients with newly diagnosed, histologically confirmed, non-metastatic, HR-PCa who are scheduled to receive RALP will be eligible to participate in the study.
Approximately, 29 cancer patients will be enrolled. Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. Patients with HR-PCa who are in the upper tercile of Decipher genomic risk (≥0.85) or have pathologically node-positive disease after lymph node dissection will receive 3 months of adjuvant AAB beginning two months post-RALP, as this is SOC for this type of patient. Node positive patients will also receive adjuvant pelvic radiation as this is SOC for this type of patient. The primary objectives of the study will be to assess the feasibility and safety of adding HDR-B prior to RALP for patients with newly diagnosed HR-PCa and to measure per-protocol treatment compliance. Patients will be on the study for a total of up to 27 months, including 2-3 months on active study intervention (HDR-B with RALP 4-8 weeks post HDR-B) and potentially an additional 3 months (AAB). Study follow-ups will be performed per-protocol for up to 2 years after surgery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
All patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. Patients with high genomic risk or node positivity will receive short course adjuvant AAB.
Houston Methodist
Houston, Texas, United States
RECRUITINGIncidence of Adverse Events
to assess the feasibility and safety of neoadjuvant HDR-B prior to RALP
Time frame: up to two years post RALP
Treatment Completion
to assess rate of treatment completion per protocol
Time frame: up to two years post RALP
Quality of Life survey
to assess HRQOL as measured by International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite (Epic 26). These are Validated Questionnaires that will be completed by participants at Baseline and at 3, 6, 9, 12, 18, and 24 months following brachytherapy. The IPSS has 7 questions, and the total Score can be between 0 and 35. The IPSS has 26 questions, and the total Score can be from 0 to100.
Time frame: up to two years post RALP
Clinical and Pathological response
to asses clinical and pathological response. Clinical response will be measured with prostate specific antigen (PSA) and multi-parametric MRI of the prostate will be obtained at baseline and immediately preceding RALP (within 2 weeks). Pathological response will be measured with tumor assessments that will be performed at the time of prostatectomy. Margin status, treatment response (no response, partial response, complete response, extraprostatic extension, LVSI, PNI, and number of resected lymph nodes will be assessed. \[ Time Frame: RALP 4-8 weeks post HDR-B\]
Time frame: up to two years post RALP
Biochemical recurrence
Biochemical recurrence (BCR) will be assessed by serial serum prostate specific antigen (PSA) measurements performed at designated study visits and as clinically indicated. Two consecutive PSA measurements ≥0.2 ng/mL
Time frame: up to two years post RALP
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Regional and distant metastasis
Locoregional and distant metastasis-free survival will be assessed by scheduled and symptom-driven imaging (CT, MRI, bone scan, or PET per protocol) and biopsy when clinically indicated.
Time frame: up to two years post RALP