A Pragmatic Phase 2 Trial of Risk-Adapted Treatment Approaches Including Treatment De-escalation to Minimize Adverse Effects of Hormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
研究概览
简要总结
This is a prospective, interventional, non-randomized, phase 2 study to assess oncologic outcomes of metastatic hormone-sensitive prostate cancer (mCSPC) patients who receive a risk-adapted treatment approach followed by treatment de-escalation at the Medstar Health network. A pragmatic design will be implemented in order to make the study available to patients at greatest needs from minority populations in the community. Additional assessments include quality-of-life (QoL) and sexual function changes as well as correlative studies. A maximum of 108 patients will be enrolled in this study. The investigators hypothesize that with a risk-adapted treatment approach followed by treatment de-escalation, more than 50% of patients will have radiographic progression-free survival (rPFS) at 36 months. Additionally, the investigators hypothesize that the risk-stratified de-escalation approach will result in fewer treatment-related adverse events and better QoL, compared to historical controls.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult patients with metastatic castrate sensitive prostate cancer that are eligible for standard of care (SOC) per treating physician.
- •a. Low risk SOC: ADT + ARPI + radiation to the prostate i. For patients with low-risk disease (defined in Section 8.1), prior treatment with ADT or ARPI for up to 8 weeks for mCSPC is permitted; however, prior treatment with docetaxel is not allowed.
- •b. High risk SOC: ADT + ARPI +/- docetaxel i. For patients with high-risk disease (defined in Section 8.1), prior treatment with ADT, ARPI, or docetaxel for up to 8 weeks for mCSPC is permitted.
- •Patients who can give informed consent and are willing to comply with follow-up visits and treatment plans.
排除标准
- •Patients for whom, in the opinion of the investigator, participation in the study, use of the drugs outlined in the study, or use of the risk-adapted treatment de-escalation strategy is not appropriate or safe.
- •Patients who have received prior treatment with any of the following:
- •Chemotherapy other than docetaxel for prostate cancer any time prior to enrollment;
- •Radiopharmaceuticals for prostate cancer any time prior to enrollment.
- •Patients who have received treatment with radiotherapy (EBRT, brachytherapy, or radiopharmaceuticals) within 2 weeks before prior to the start of study treatment.
- •Patients with prior treatment with an ARPI for non-metastatic disease within 6 months of diagnosis of metastatic disease are not eligible.
- •a. Note: Patients who were diagnosed with metastatic disease or more than 6 months after treatment with an ARPI non-metastatic disease are eligible.
- •Patients who had previous (within 28 days before the start of study drug or 4 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).
- •Patients with an inability to swallow oral medications in the opinion of the clinical investigator.
- •Patients with leptomeningeal disease.
研究组 & 干预措施
Low Risk Prostate Cancer
Low risk patients will receive 6-month doublet therapy with Androgen Deprivation Therapy (ADT) + Androgen Receptor Pathway Inhibitor (ARPI) + prostate radiation with or without radiation to metastatic sites followed by 30 months ARPI monotherapy. At a 36-month timepoint, those who maintain a prostate specific antigen (PSA) ≤ 0.2ng/mL will have the option to either discontinue treatment proceeding with active surveillance or continue on their ARPI until disease progression or intolerable toxicity. Patients who discontinue ARPI will resume ARPI and ADT when the PSA ≥ 2 ng/mL above the lowest PSA on two consecutive checks at least 1 month apart, there is evidence of progressive disease (PD) on conventional scans [CT/MRI imaging per modified RECIST 1.1 or bone scan per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)], clinical symptoms of progression, or if the patient prefers to continue ARPI and ADT.
干预措施: Androgen Deprivation Therapy (ADT) (Drug)
Low Risk Prostate Cancer
Low risk patients will receive 6-month doublet therapy with Androgen Deprivation Therapy (ADT) + Androgen Receptor Pathway Inhibitor (ARPI) + prostate radiation with or without radiation to metastatic sites followed by 30 months ARPI monotherapy. At a 36-month timepoint, those who maintain a prostate specific antigen (PSA) ≤ 0.2ng/mL will have the option to either discontinue treatment proceeding with active surveillance or continue on their ARPI until disease progression or intolerable toxicity. Patients who discontinue ARPI will resume ARPI and ADT when the PSA ≥ 2 ng/mL above the lowest PSA on two consecutive checks at least 1 month apart, there is evidence of progressive disease (PD) on conventional scans [CT/MRI imaging per modified RECIST 1.1 or bone scan per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)], clinical symptoms of progression, or if the patient prefers to continue ARPI and ADT.
干预措施: Prostate Radiation (Radiation)
Low Risk Prostate Cancer
Low risk patients will receive 6-month doublet therapy with Androgen Deprivation Therapy (ADT) + Androgen Receptor Pathway Inhibitor (ARPI) + prostate radiation with or without radiation to metastatic sites followed by 30 months ARPI monotherapy. At a 36-month timepoint, those who maintain a prostate specific antigen (PSA) ≤ 0.2ng/mL will have the option to either discontinue treatment proceeding with active surveillance or continue on their ARPI until disease progression or intolerable toxicity. Patients who discontinue ARPI will resume ARPI and ADT when the PSA ≥ 2 ng/mL above the lowest PSA on two consecutive checks at least 1 month apart, there is evidence of progressive disease (PD) on conventional scans [CT/MRI imaging per modified RECIST 1.1 or bone scan per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)], clinical symptoms of progression, or if the patient prefers to continue ARPI and ADT.
干预措施: Androgen Receptor Pathway Inhibitor (ARPI) (Drug)
High Risk Prostate Cancer
High-risk patients will receive triplet therapy with ADT + ARPI + 6 cycles of docetaxel followed by 18-months of ADT + ARPI and then 12-month ARPI monotherapy. If a patient has high-risk disease but, based on the investigator's judgment, has contraindications to docetaxel or is deemed unsuitable for it, they will receive the same treatment regimen as other high-risk patients minus the docetaxel. Then at a 36-month timepoint, those who maintain a PSA ≤ 0.2ng/mL will have the option to either discontinue treatment with active surveillance or continue ARPI until disease progression or intolerable toxicity. Patients who discontinue ARPI will resume ARPI and ADT when the PSA ≥ 2 ng/mL above the lowest PSA (nadir) on two consecutive checks at least 1 month apart, there is evidence of progressive disease (PD) on conventional scans [CT/MRI imaging per modified RECIST 1.1 or bone scan per PCWG3], clinical symptoms of progression, or if the patient prefers to continue ARPI and ADT.
干预措施: Androgen Deprivation Therapy (ADT) (Drug)
High Risk Prostate Cancer
High-risk patients will receive triplet therapy with ADT + ARPI + 6 cycles of docetaxel followed by 18-months of ADT + ARPI and then 12-month ARPI monotherapy. If a patient has high-risk disease but, based on the investigator's judgment, has contraindications to docetaxel or is deemed unsuitable for it, they will receive the same treatment regimen as other high-risk patients minus the docetaxel. Then at a 36-month timepoint, those who maintain a PSA ≤ 0.2ng/mL will have the option to either discontinue treatment with active surveillance or continue ARPI until disease progression or intolerable toxicity. Patients who discontinue ARPI will resume ARPI and ADT when the PSA ≥ 2 ng/mL above the lowest PSA (nadir) on two consecutive checks at least 1 month apart, there is evidence of progressive disease (PD) on conventional scans [CT/MRI imaging per modified RECIST 1.1 or bone scan per PCWG3], clinical symptoms of progression, or if the patient prefers to continue ARPI and ADT.
干预措施: Androgen Receptor Pathway Inhibitor (ARPI) (Drug)
High Risk Prostate Cancer
High-risk patients will receive triplet therapy with ADT + ARPI + 6 cycles of docetaxel followed by 18-months of ADT + ARPI and then 12-month ARPI monotherapy. If a patient has high-risk disease but, based on the investigator's judgment, has contraindications to docetaxel or is deemed unsuitable for it, they will receive the same treatment regimen as other high-risk patients minus the docetaxel. Then at a 36-month timepoint, those who maintain a PSA ≤ 0.2ng/mL will have the option to either discontinue treatment with active surveillance or continue ARPI until disease progression or intolerable toxicity. Patients who discontinue ARPI will resume ARPI and ADT when the PSA ≥ 2 ng/mL above the lowest PSA (nadir) on two consecutive checks at least 1 month apart, there is evidence of progressive disease (PD) on conventional scans [CT/MRI imaging per modified RECIST 1.1 or bone scan per PCWG3], clinical symptoms of progression, or if the patient prefers to continue ARPI and ADT.
干预措施: Docetaxel (Drug)