Clinical trial NCT06060587: Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone
Official title: A Randomized Phase II Study of ADT + Abiraterone Versus ADT + Docetaxel + Abiraterone in Patients With Low Volume Metastatic Hormone Sensitive Prostate Cancer
Conditions: Prostate Cancer
Summary: This is a phase II, randomized, open label study comparing first line therapy with AThis is a phase II, randomized, open label study comparing first line therapy with ADT + abiraterone (doublet arm) or ADT + abiraterone + docetaxel (triplet arm) in low volume, metastatic hormone sensitive prostate cancer (mHSPC).
This is a phase II, randomized, open label study comparing first line therapy with Androgen Deprivation Therapy (ADT) + abiraterone (doublet arm) or ADT + abiraterone + docetaxel (triplet arm) in low volume, metastatic hormone sensitive prostate cancer (mHSPC).
The hypothesis being asked in this trial is whether first line treatment with ADT plus an androgen receptor pathway inhibitor (abiraterone) as a doublet regimen compared to ADT plus an androgen receptor pathway inhibitor (abiraterone) and docetaxel, as a triplet regimen results in superior outcomes for patients with low volume mHSPC.
We plan to enroll patients with mHPSC that meet the CHAARTED criteria for low disease volume. Patients will be randomized 1:1 to either treatment arm:
* doublet arm: abiraterone +ADT or
* triplet arm: abiraterone + ADT + docetaxel.
All subjects must receive ADT of the Investigator's choice (LHRH agonist/antagonists or orchiectomy) as standard therapy, started = 12 weeks before randomization.
Interventions:
description: 75 mg/m2 via IV
name: Docetaxel
type: Drug
description: Prior to randomization as part of standard of care.
name: ADT
type: Drug
description: 1000 mg by mouth
name: Abiraterone
type: Drug
Study arms:
design_group_description: Abiraterone+Docetaxel+ADT<br/>Abiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle.<br/>Abiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets.<br/>Docetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion.<br/>ADT Patients may be started on an LHRH agonist or antagonist , the selection of the agent is left to the treating investigator for ADT.
design_group_title: Triplet Arm
design_group_type: Experimental
design_group_description: Abiraterone+ADT<br/>Abiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle.<br/>Treatment of abiraterone should start ≤14 days after patient randomization.<br/>Abiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets.<br/>Docetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Prior to docetaxel, dexamethasone administration is recommended as discussed, but can be adjusted or altered per the treating investigator's discretion. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion.
design_group_title: Doublet Arm
design_group_type: Active Comparator
Sponsor: Northwestern University
Collaborators: National Cancer Institute
Drug name mappings:
name: 醋酸阿比特龙
lang: CN
name: Abiraterone acetate
lang: EN
name: アビラテロン酢酸エステル
lang: JP
name: 多西他赛
lang: CN
name: Docetaxel
lang: EN
name: ドセタキセル
lang: JP