NCT07325721招募中2 期
Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- CTCAE grade 2 or higher acute genitourinary toxicity
研究概览
简要总结
This study is for adult men with previously untreated high risk, very high risk, or pelvic lymph node positive prostate cancer. The purpose of this study is to evaluate the safety and effectiveness of the combination of two emerging radiation treatment techniques (hypofractionated radiotherapy and microboost technique). Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. There is optional banking of blood and prostate biopsy tissue which will not require extra biopsies. Participation in this study is anticipated to last approximately 6 weeks with follow up every three months for two years then twice yearly for years 3-5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Biologically male patients aged 18 years and older.
- •Ability to receive pelvic radiotherapy and be willing to adhere to the protocol regimen.
- •Previously untreated prostate cancer (with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy). Prior transurethral resection of prostate (TURP) is permitted if 90 days or more prior to the start of radiotherapy.
- •Localized or locally advanced prostate cancer meeting NCCN criteria for high risk, very high risk or non-metastatic, pelvic lymph node positive defined as having at least one or more of the following:
- •PSA >20 ng/mL prior to starting ADT.
- •cT3a-T4 by digital exam or imaging.
- •Gleason score of 8-10 (grade group 4 or 5).
- •Staged as N1M0 by the treating investigator (pelvic lymph node positive, below the aortic bifurcation) based on soft tissue imaging within 120 days prior to registration (may include CT, MRI or PSMA PET/CT, of fluciclovine choline PET/CT).
- •History and physical exam within 120 days prior to registration.
- •ECOG performance status 0-
- •Be able to undergo MRI of the prostate and/or pelvis as a component of RT planning.
- •Have at least one MRI visible target for microboost (PI-RADS≥ 4 version 2.0).
- •Bone and soft tissue imaging as clinically indicated for staging within 120 days prior to registration.
- •For males: use of condoms or other methods to ensure effective contraception with partner during radiation and for six months after completion of radiation.
- •Adequate hematologic function within 120 days prior to registration as defined by:
- •hemoglobin >=9.0 g/dL independent of transfusion, and
- •platelet count >= 100,000 x 10 ^9/microliter independent of transfusion.
- •Adequate hepatic function within 120 days prior to registration defined as total bilirubin <2 x institutional upper limits of normal (ULN is 1.2 mg/dL). If labs are done at outside institution, total bilirubin should be <2.
- •Agreeable and eligible to receive long term (defined as 12-36 months) ADT as a standard component of prostate cancer therapy.
排除标准
- •1. Concurrent use of testosterone supplementation unless discontinued by time of registration.
- •2. Definitive radiologic evidence of metastatic disease outside of the pelvic nodes on conventional imaging (bone scan, CT scan, MRI).
- •3. Prior pelvic radiotherapy.
- •Pre-existing conditions or overall health status which disqualifies the patient from curative intent-RT. Patients with life expectancy less than 5 years are not eligible.
- •5. Treatment with another investigational prostate cancer therapy within 12 months.
- •6. Prior total prostatectomy, cryotherapy, high-intensity focused ultrasound, irreversible electroporation, MRI ablation, laser ablation, transurethral ultrasound ablation, aquablation directed towards the prostate for any prostate disease or condition.
- •7. Prior or concurrent invasive pelvic malignancy (except non-melanomatous skin cancer) or lymphomatous or hematogenous malignancy, unless disease free for a minimum of 5 years.
- •8. Any condition that, in the opinion of the investigator, would preclude participation in this study.
- •9. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 90 days prior to registration.
- •10. Inability to undergo implantation of gold fiducial markers or rectal spacer gel.
- •11. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
研究组 & 干预措施
Hypofractationed pelvic radiation with microboost
Experimental
干预措施: Hypofractionated radiation with a microboost (Radiation)
结局指标
主要结局
CTCAE grade 2 or higher acute genitourinary toxicity
时间窗: 1 month post radiation
次要结局
- PSA failure rate(2 years)
- grade 2 or higher acute GI toxicity, late GU toxicity and late GI toxicity(5 years)
- death from any cause(5 years)
- Mean change in Sexual Health Inventory for Men (SHIM) score(5 years)
- Mean change in EPIC-26 sexual domain score from baseline(1 year)
研究者
研究点 (1)
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