Apalutamide With or Without Stereotactic Body Radiation Therapy in Treating Participants With Castration-Resistant Prostate Cancer (PILLAR) (PILLAR)
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|ClinicalTrials.gov Identifier: NCT03503344|
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : December 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Castration Levels of Testosterone Castration-Resistant Prostate Carcinoma PSA Progression Stage IV Prostate Adenocarcinoma AJCC v7||Drug: Apalutamide Radiation: Stereotactic Body Radiation Therapy||Phase 2|
I. To demonstrate whether the proportion of patients with an undetectable serum prostate specific antigen (PSA) at 6 months following cessation of apalutamide is higher with addition of stereotactic body radiation therapy (SBRT) to prostate specific membrane antigen (PSMA)-avid oligometastatic sites of disease compared to the group of patients receiving apalutamide monotherapy.
I. To compare the time to PSA progression by Prostate Cancer Working Group (PCWG) criteria between treatment arms.
II. To compare radiologic progression free survival (rPFS) between treatment arms.
III. To evaluate the safety and tolerability of apalutamide in combination with SBRT.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive apalutamide orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Beginning 60 days after first dose of apalutamide, participants also undergo stereotactic body radiation therapy for 1-5 fractions.
ARM II: Participants receive apalutamide PO QD on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed at for 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Phase II Study of Apalutamide +/- Stereotactic Body Radiotherapy (SBRT) in Castration-Resistant Prostate Cancer Patients With Oligometastatic Disease on PSMA-PET Imaging|
|Actual Study Start Date :||December 17, 2019|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: Arm I (apalutamide, SBRT)
Participants receive apalutamide PO QD on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Beginning 60 days after first dose of apalutamide, participants also undergo stereotactic body radiation therapy for 1-5 fractions.
Given PO, 240 mg per day (4 x 60mg tablets)
Radiation: Stereotactic Body Radiation Therapy
Active Comparator: Arm II (SBRT)
Participants receive apalutamide PO QD on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Given PO, 240 mg per day (4 x 60mg tablets)
- Proportion of patients with undetectable serum prostate specific antigen [ Time Frame: Approximately 18 months from date of randomization ]The primary endpoint for the study is the proportion of patients with undetectable serum PSA (< 0.2 ng/mL) at 6 months following completion of apalutamide therapy (18 months from date of randomization). Fisher's exact test will be used to compare the proportion in the two treatment arms. Patients who discontinue apalutamide prior to completion of 12 months of therapy for reasons other than disease progression by Prostate Cancer Clinical Trials Working Group (PCWG) criteria, as well as patients who withdraw or are lost to follow up, will be considered inevaluable for this analysis. Patients who discontinue treatment for radiographic or clinical progression, even if occurring prior to receipt of SBRT in the experimental arm), would be evaluable for analysis of the primary endpoint.
- Time to PSA progression according to Prostate Cancer Working Group (PCWG) criteria [ Time Frame: Up to 36 months ]Comparison of time to PSA progression will be performed using a two-sided log-rank test. Kaplan-Meier methods will be used to estimate medians for each treatment arm. Cox proportional-hazard models, will be used to estimate the hazard ratio and its 95% confidence interval (CI).
- Radiologic progression free survival (rPFS) according to PCWG criteria [ Time Frame: Up to 36 months ]Comparison of time to radiographic progression-free survival will be performed using a two-sided log-rank test. Kaplan-Meier methods will be used to estimate medians for each treatment arm. Cox proportional-hazard models, will be used to estimate the hazard ratio and its 95% CI.
- Frequency of treatment-emergent adverse events (AEs) [ Time Frame: Up to 36 months ]Adverse events (AEs) will be classified according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. All AEs reported from the first dose of study drug until 30 days after the last dose of study drug will be considered as treatment-emergent AEs and will be summarized by treatment arm. For each treatment arm, all patients treated in that treatment arm will be included. Treatment-related AEs are those judged by the Investigator to be at least possibly related to the study treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503344
|Contact: Patricia Li||(415) 476-5975||Patricia.Li@ucsf.edu|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Patricia Li 415-476-5975 Patricia.Li@ucsf.edu|
|Contact 877-827-3222 email@example.com|
|Principal Investigator: Rahul R. Aggarwal, MD|
|Principal Investigator:||Rahul Aggarwal, MD||University of California, San Francisco|