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

NCT05705700 | Withdrawn Phase 2

• 1 other identifier: 2019LS229
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determine overall survival (OS)

  24 months from start of treatment assignment

• Number of patients with a PSA decline of ≥ 50%

  24 weeks of adding of adding high-dose dutasteride

Study Arms (3)

1245c positive (1245c+) patients with dutasteride

EXPERIMENTAL

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: Dutasteride; Drug: Abiraterone

1245c positive (1245c+) patients

EXPERIMENTAL

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

Drug: Abiraterone

1245c negative (1245c-) patients

EXPERIMENTAL

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

Drug: Abiraterone

Interventions

Dutasteride DRUG

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

Also known as: Abiraterone

1245c positive (1245c+) patients with dutasteride

Abiraterone DRUG

1000 mg PO daily

Also known as: Dutasteride

1245c negative (1245c-) patients; 1245c positive (1245c+) patients; 1245c positive (1245c+) patients with dutasteride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dutasteride; abiraterone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Charles Ryan, MD

  Masonic Cancer Center, Univeristy of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 31, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share