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

NCT ID: NCT05705700

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2030-01-31

Brief 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Dutasteride

Intervention Type: DRUG

High dose Dutasteride (3.5 mg daily) as add-on therapy at time of PSA progression

Abiraterone

Intervention Type: DRUG

1000 mg PO daily

1245c positive (1245c+) patients

Continue on abiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented

Group Type: EXPERIMENTAL

Abiraterone

Intervention Type: DRUG

1000 mg PO daily

1245c negative (1245c-) patients

abiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented

Group Type: EXPERIMENTAL

Abiraterone

Intervention Type: DRUG

1000 mg PO daily

Interventions

Dutasteride

High dose Dutasteride (3.5 mg daily) as add-on therapy at time of PSA progression

Intervention Type: DRUG

Abiraterone

1000 mg PO daily

Intervention Type: DRUG

Other Intervention Names

Abiraterone; Dutasteride

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Ryan, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, Univeristy of Minnesota

Other Identifiers

2019LS229

Identifier Type: -

Identifier Source: org_study_id