A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer (ASCLEPIuS)
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|ClinicalTrials.gov Identifier: NCT04194554|
Recruitment Status : Not yet recruiting
First Posted : December 11, 2019
Last Update Posted : December 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Niraparib Drug: Leuprolide Drug: Abiraterone Acetate Radiation: Stereotactic body radiotherapy (SBRT)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Time to Event Continual Reassessment Method (TITE-CRM) dose-finding clinical trial design.|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center Trial of Androgen Suppression With Abiraterone aCetate, LEuprolide, PARP Inhibition and Stereotactic Body Radiotherapy (ASCLEPIuS): A Phase I/2 Trial in High Risk and Node Positive Prostate Cancer|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||March 2026|
|Estimated Study Completion Date :||September 2026|
Experimental: Niraparid Dose Escalation
Dose Level 1: 100 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT
Dose Level 2: 200 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT
Dose Level 3: 200 mg PO daily of Niraparib without breaks during SBRT until completion of 6 cycles.
given PO per dose escalation schedule
22.5 mg q3 month
Drug: Abiraterone Acetate
1000 mg daily
Radiation: Stereotactic body radiotherapy (SBRT)
5-6 fraction SBRT (total dose: 37.5-40 Gy)
Other Name: Ultra-hypofractionated radiotherapy
- Dose-limiting toxicities (Phase 1) [ Time Frame: Up to 112 days after initial dose of niraparib ]The proportion of patients at each dose level with dose-limiting toxicity (DLT), defined as any treatment related grade 3-5 adverse event experienced within the first 4 treatment cycles (112 days), assessed per NCI's CTCAE version 5.0.
- Proportion of patients experiencing biochemical failure [ Time Frame: Up to 3 years after first dose of niraparib ]Change in PSA level from the beginning of study treatment for up to 3 years later will determine the biochemical failure rate. Biochemical failure will be defined using the Phoenix definition of the PSA nadir + 2 ng/mL.
- Change in health related quality of life [ Time Frame: From baseline up to 3 years after last dose of niraparib ]Assessed via EPIC-26 questionnaire
- Proportion of patients with undetectable post-treatment PSA [ Time Frame: Measured during the end of the 6th cycle of therapy (during week 24 +/- 7 days) ]Undetectable PSA will be defined as a PSA ≤0.1 ng/mL.
- Proportion of patients with distant metastases [ Time Frame: Up to 5 years after first dose of niraparib ]Distant metastases will be defined as any clinical or radiographic evidence of lymph node, bone, or visceral involvement of prostate cancer.
- Prostate cancer specific survival [ Time Frame: Up to 5 years after first dose of niraparib ]Prostate cancer specific survival will be defined as the duration of time from the start of treatment to death attributable to prostate cancer. Patients who have not died or die of non-prostate cancer related causes will be censored at the last known follow-up or date of death, respectively. Summarized using cumulative incidence or Kaplan-Meier curves as appropriate.
- Overall survival [ Time Frame: Up to 5 years after first dose of niraparib ]Overall survival (OS) will be defined as the duration of time from the start of treatment to death from any cause. Patients who have not died will be censored at the last known follow-up.Summarized using cumulative incidence or Kaplan-Meier curves as appropriate.
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): NCT04194554
|United States, Michigan|
|University of Michigan Rogel Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Daniel Spratt, M.D. email@example.com|
|Principal Investigator: Daniel Spratt, M.D.|