Prostate Cancer (Adenocarcinoma)
Conditions
Keywords
high risk prostate cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGBrachytherapy
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.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must have biopsy-confirmed adenocarcinoma of the prostate. 2. Subjects must have a negative bone scan and CT scan or PSMA-PET for nodal or metastatic disease. 3. Subjects must have one of the following risk factors: * PSA ≥20 and/or * Gleason score ≥8 and/or * Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 8th Edition Staging Manual and/or * At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS (Gleason Score) = 4+3, clinical stage = T2b/T2c, ≥50% positive biopsy cores. 4. Subjects must freely sign informed consent to enroll in the study. 5. Subjects must be medically fit to undergo surgery and HDR-B as determined by the PI. 6. Age ≥ 40 7. ECOG Performance Status (performance status is an attempt to quantify cancer patients\' general well-being and activities of daily life, scores range from 0 to 5 where 0 represents perfect health and 5 represents death): 0-1. 8. No prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer unless disease free for a minimum of 2 years. Carcinoma in-situ of the bladder or head and neck region is permissible. 9. Subjects must not have had prior androgen deprivation therapy in the past 6 months.
Exclusion criteria
1. Metastatic disease as demonstrated by bone scan, CT scan, MRI of the pelvis, or PSMA-PET. 2. Declared high-risk for anesthesia by attending cardiologist, or other physician. 3. History of prior pelvic radiation therapy. 4. Prostate gland \>70 cc as assessed by MRI or TRUS. 5. Baseline IPSS \>15 with medical optimization. 6. History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \> 3 mo. prior to enrollment). 7. Unwilling or unable to comply with the study protocol. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | up to two years post RALP | to assess the feasibility and safety of neoadjuvant HDR-B prior to RALP |
| Treatment Completion | up to two years post RALP | to assess rate of treatment completion per protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in International Prostate Symptom Score (IPSS) | Baseline; 3, 6, 9, 12, 18, and 24 months after robot-assisted laparoscopic prostatectomy (RALP) | Urinary health-related quality of life will be assessed using the International Prostate Symptom Score (IPSS). The IPSS questionnaire consists of 7 questions evaluating urinary symptoms. Total scores range from 0 to 35, with higher scores indicating more severe urinary symptoms. Change from baseline will be calculated at each follow-up time point. |
| Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC-26) Score | Baseline; 3, 6, 9, 12, 18, and 24 months after robot-assisted laparoscopic prostatectomy (RALP) | Health-related quality of life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC-26), a validated questionnaire that evaluates urinary, bowel, sexual, and hormonal domains in patients with prostate cancer. Scores range from 0 to 100, with higher scores indicating better quality of life. Change from baseline will be calculated at each follow-up time point. |
| Change in Prostate-Specific Antigen (PSA) | Baseline and within 2 weeks prior to RALP (4-8 weeks after HDR brachytherapy) | Clinical response will be assessed by the change in serum prostate-specific antigen (PSA) levels from baseline to immediately prior to robot-assisted laparoscopic prostatectomy (RALP). |
| Radiologic Tumor Response on Multiparametric MRI (mpMRI) | Baseline and within 2 weeks prior to RALP | Radiologic response will be evaluated using multiparametric MRI of the prostate performed at baseline and immediately prior to RALP to assess changes in tumor characteristics. |
| Pathologic Response in Prostatectomy Specimen | At RALP (4-8 weeks after HDR brachytherapy) | Pathologic response will be assessed in the prostatectomy specimen and categorized as complete response, partial response, or no response. |
| Biochemical recurrence | up to 24 months post RALP | Biochemical recurrence (BCR) will be assessed using serial serum prostate-specific antigen (PSA) measurements obtained at scheduled study visits and as clinically indicated. BCR will be defined as two consecutive PSA measurements ≥0.2 ng/mL following robot-assisted laparoscopic prostatectomy (RALP). |
| Regional and distant metastasis | Up to 24 months after RALP | Locoregional and distant metastasis-free survival will be defined as the time from robot-assisted laparoscopic prostatectomy (RALP) to the first documented evidence of locoregional or distant metastatic disease. Metastatic disease will be assessed through scheduled or symptom-driven imaging studies, including computed tomography (CT), magnetic resonance imaging (MRI), bone scan, or positron emission tomography (PET), with biopsy confirmation when clinically indicated. |
Countries
United States
Contacts
CONTACTVivian MacDonnell, CCRP
CONTACTAndrew Fararch, MD
PRINCIPAL_INVESTIGATORAndrew Farach, MD
The Methodist Hospital Reseach Institute
Outcome results
None listed