A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer
概览
- 阶段
- 不适用
- 干预措施
- Triptorelin Pamoate
- 疾病 / 适应症
- Prostate Adenocarcinoma
- 发起方
- Stanford University
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v3.0
- 状态
- 进行中（未招募）
- 最后更新
- 19天前
概览
简要总结
This trial studies the side effects and how well high-dose brachytherapy works in treating patients with prostate cancer that has not spread to other parts of the body. Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor and may be a better treatment in patients with prostate cancer.
详细描述
PRIMARY OBJECTIVES: To estimate the rate of acute (within 6 months of high-dose rate \[HDR\] completion) grade ≥ 2 genitourinary (GU) toxicity following high-dose-rate (HDR) brachytherapy (BT) as monotherapy for newly-diagnosed prostate cancer using the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3 (CTCAE v3.0). SECONDARY OBJECTIVES: * Estimate the proportion of men with a prostate-specific antigen (PSA) nadir by one year (nPSA12) of \< 2 ng/mL. * Estimate the rate of freedom from biochemical failure at 5 years (FFBF). * Evaluate patient-reported quality of life via the 32-item Expanded Prostate Cancer Index Composite (EPIC). * Assess the cost-effectiveness of HDR BT as monotherapy for prostate cancer using the 6-item European Quality of Life 5-Dimensions (EQ-5D). * Explore pre-treatment clinical risk factors to optimize patient selection for HDR BT as monotherapy for prostate cancer. * Compare acute and late (\> 6 months after HDR completion) GU and gastrointestinal (GI) grade ≥ 2 toxicity using CTCAE v3.0 and v4.0. * Explore dosimetric predictors of toxicity. Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients may receive androgen deprivation therapy (ADT) comprising bicalutamide orally (PO) once daily (QD). Patients may also receive luteinizing hormone-releasing hormone (LHRH) agonist therapy comprising leuprolide acetate intramuscularly (IM) or subcutaneously (SC), goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4 to 6 months (intermediate-risk patients receiving ADT) or 6 to 36 months (high-risk patients) at the discretion of the treating physician. After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months, and then yearly for up to 5 years.
研究者
入排标准
入选标准
- •Documented pathologic confirmation of prostate adenocarcinoma
- •Clinical T-classification T1-3
- •PSA \< 150 ng/mL
- •Gleason score 6-10
- •Clinically negative lymph nodes as established by abdomino-pelvic CT. CT only for clinical classification of T3 (with contrast if renal function is acceptable; a non-contrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection. Patients with lymph nodes equivocal or questionable by imaging are eligible if those nodes are \<1 cm in short axis diameter. \[56\]
- •No evidence of bone metastases (M0) on bone scan, only for PSA \>20 ng/mLor Gleason ≥8, (NaF PET/CT is an acceptable substitute). Equivocal bone scan findings are allowed if plain films and/or MRI are negative for definite metastases.
- •American Urological Association Symptom Index (AUA SI) =\< 20
排除标准
- •Clinical T4 disease
- •PSA \>= 150 ng/mL
- •AUA SI \> 20
- •History of radical prostatectomy, external beam radiotherapy (EBRT), or BT for prostate cancer
- •Previous chemotherapy for any malignancy, if given within three years of registration
- •History of rectal surgery
- •History of rectal fistula
- •History of inflammatory bowel disease
- •Severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last six months
研究组 & 干预措施
Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)
Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.
干预措施: Triptorelin Pamoate
Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)
Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.
干预措施: Degarelix
Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)
Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.
干预措施: Laboratory Biomarker Analysis
Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)
Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.
干预措施: Internal Radiation Therapy
Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)
Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.
干预措施: Quality-of-Life Assessment
Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)
Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.
干预措施: Leuprolide Acetate
Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)
Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.
干预措施: Goserelin Acetate
Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)
Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.
干预措施: Bicalutamide
结局指标
主要结局
Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v3.0
时间窗: Within 6 months of HDR completion
Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
次要结局
- Proportion of men with a nPSA12 of < 2 ng/mL(Up to 1 year after completion of HDR)
- FFBF (Biochemical failure define according to PSA nadir+2ng/mL and 3 consecutive rises definition according to American Society of Radiation Oncology(From the completion of all treatment to the time of BF, assessed at 5 years)
- Change in quality of life as measured by EPIC scores(Baseline to up to 5 years)
- Cost-effectiveness of HDR BT as monotherapy for prostate cancer using as measured by EQ-5D scores(Up to 5 years)
- Pre-treatment clinical risk factors to optimize patient selection for HDR BT as monotherapy for prostate cancer (association between each risk factor and the risk of having a first BF)(Baseline)
- Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v4.0(Within 6 months of HDR completion)
- Late GU toxicity, scored according to CTCAE v3.0 and v4.0(Up to 5 years)
- Acute GI toxicity scored according to CTCAE v3.0 and CTCAE v4.0(Up to 6 months after completing HDR BT)
- Late GI toxicity, scored according to CTCAE v3.0 and CTCAE v4.0(Up to 5 years)
- Dosimetric predictors of toxicity (Doses to pelvic structures will be calculated and reviewed to determine possible correlations with toxicity outcomes)(Up to 5 years)