High Dose Rate Brachytherapy Prior to Robotic Assisted Laparoscopic Prostatectomy With Selective Adjuvant Androgen Blockade for Localized High-risk Prostate Cancer (NEOHDR-B)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
- •Subjects must have a negative bone scan and CT scan or PSMA-PET for nodal or metastatic disease.
- •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.
- •Subjects must freely sign informed consent to enroll in the study.
- •Subjects must be medically fit to undergo surgery and HDR-B as determined by the PI.
- •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-
- •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.
- •Subjects must not have had prior androgen deprivation therapy in the past 6 months.
排除标准
- •Metastatic disease as demonstrated by bone scan, CT scan, MRI of the pelvis, or PSMA-PET.
- •Declared high-risk for anesthesia by attending cardiologist, or other physician.
- •History of prior pelvic radiation therapy.
- •Prostate gland >70 cc as assessed by MRI or TRUS.
- •Baseline IPSS >15 with medical optimization.
- •History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued > 3 mo. prior to enrollment).
- •Unwilling or unable to comply with the study protocol.
研究组 & 干预措施
Decipher < 0.85
Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP.
干预措施: Brachytherapy (Drug)
Decipher ≥0.85 with AAB
Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. In addition, patients with high genomic risk (≥0.85) will receive AAB for 12 weeks in the adjuvant setting beginning 8 weeks post RALP. Patients will receive an androgen receptor inhibitor per treating physician discretion (darolutamide 600 mg PO BID, enzalutamide 160 mg PO QD, apalutamide 240 mg PO QD, or bicalutamide 50 mg PO QD). In addition, patients will receive either a GnRH antagonist (relugolix 360 mg PO x 1 day followed by 120 mg PO QD) or a GnRH agonist (leuprolide 22.5 mg SC once or goserelin 10.8 mg SC once). Pathologically node positive patients will receive adjuvant pelvic radiation therapy as is SOC once the patient has recovered from surgery.
干预措施: Brachytherapy (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: up to two years post RALP
to assess the feasibility and safety of neoadjuvant HDR-B prior to RALP
Treatment Completion
时间窗: up to two years post RALP
to assess rate of treatment completion per protocol
次要结局
- Change From Baseline in International Prostate Symptom Score (IPSS)(Baseline; 3, 6, 9, 12, 18, and 24 months after robot-assisted laparoscopic prostatectomy (RALP))
- 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))
- Change in Prostate-Specific Antigen (PSA)(Baseline and within 2 weeks prior to RALP (4-8 weeks after HDR brachytherapy))
- Radiologic Tumor Response on Multiparametric MRI (mpMRI)(Baseline and within 2 weeks prior to RALP)
- Pathologic Response in Prostatectomy Specimen(At RALP (4-8 weeks after HDR brachytherapy))
- Biochemical recurrence(up to 24 months post RALP)
- Regional and distant metastasis(Up to 24 months after RALP)
研究者
Andrew Farach
Principal Investigator
The Methodist Hospital Research Institute