Biomarker Study of in Men With PSA Progression on Abi for CR or CS PC (Bio-STAMP)

Biomarker Study Targeting Abiraterone Metabolites and Polymporphisms in Men With PSA Progression on Abiraterone for the Treatment of Castration Resistant or Castration Sensitive Prostate Cancer (The Bio-STAMP Study)

This is a multicenter, Phase II randomized biomarker-based therapeutic study in metastatic prostate cancer experiencing prostate specific antigen (PSA) only progression (without visceral, bone or lymph node progression) while on abiraterone therapy.

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Abiraterone; Drug: Dutasteride

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Charles Ryan, MD; Phone Number: 612-624-9487; Email: ryanc@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histological or cytological evidence of adenocarcinoma of the prostate
• Undergone orchiectomy, or have been on luteinizing hormone-releasing hormone (LHRH) agonists or antagonists for at least 3 months prior to study enrollment. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study.
• Currently receiving abiraterone (ZYTIGA or FDA approved generic) in the castration sensitive (CSPC) or castration resistant (CRPC) setting with PSA progression in the absence of visceral, bone or lymph node progression. PSA progression is defined as an increase in the PSA level of more than 50% above the nadir with two consecutive increases at least 2 weeks apart (based on Prostate Cancer Working Group Criteria, version 3 (PCWG3).
• Minimum PSA must be ≥1.0 ng/dL.
• Age 18 years of age or older.
• ECOG performance status 0 or 1.

• Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to enrollment:

  • absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
  • platelets ≥ 100 × 10^9/L
  • hemoglobin ≥ 10 g/dL, independent of transfusion ≤14 days of screening
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN
  • total bilirubin ≤ 1.5 × ULN; < 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome
  • serum albumin ≥ 30 g/L (3.0 g/dL)
  • Serum creatinine ≤ 1.5 x ULN; OR estimated glomerular filtration rate (GFR) ≥ 45 mL/min using the Cockcroft Gault formula

• Participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) during the dutasteride treatment period and for 6 months after last dose or 3 weeks after the last dose of abiraterone whichever is longer. Persons are considered to be of childbearing potential unless one or the following applies:

  • Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause
  • Considered permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy.
• Voluntary written consent prior to the performance of any research related activit

Exclusion Criteria:

• Previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to 5 alpha-reductase inhibitors (i.e. finasteride).
• Prior use of Enzalutamide, Apalutamide, or Darolutamide for the treatment of prostate cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1245c positive (1245c+) patients with dutasteride; Continue on abiraterone 1000 mg PO daily with dutasteride 3.5 mg PO daily as an add-on therapy until radiographic progression is documented	Drug: Abiraterone; 1000 mg PO daily; Other Names: Dutasteride; Drug: Dutasteride; High dose Dutasteride (3.5 mg daily) as add-on therapy at time of PSA progression; Other Names: Abiraterone
Experimental: 1245c positive (1245c+) patients; Continue on abiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented	Drug: Abiraterone; 1000 mg PO daily; Other Names: Dutasteride
Experimental: 1245c negative (1245c-) patients; abiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented	Drug: Abiraterone; 1000 mg PO daily; Other Names: Dutasteride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with radiographic progression free survival (rPFS) rate	Count the the number of patients with radiographic progression free survival (rPFS)	24 Weeks after study treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine overall survival (OS)	The Kaplan-Meier product-limit estimator will be used to estimate OS distribution	24 months from start of treatment assignment
Number of patients with a PSA decline of ≥ 50%	Count the number of patients with serologic progression. It is defined as an increase in the PSA level of more than 50% above the nadir with two consecutive increases confirmed at least 2 weeks apart.	24 weeks of adding of adding high-dose dutasteride

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): January 1, 2030
• Study Completion (Anticipated): January 1, 2030

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Dutasteride
• Other Study ID Numbers: 2019LS229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No