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

Prostate Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05705700
• Other study ID #: 2019LS229
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2023
• Est. completion date: January 2030

Study information

• Verified date: February 2023
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Dutasteride
High dose Dutasteride (3.5 mg daily) as add-on therapy at time of PSA progression
• Abiraterone
1000 mg PO daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine overall survival (OS)	The Kaplan-Meier product-limit estimator will be used to estimate OS distribution	24 months from start of treatment assignment
Secondary	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