Testosterone Therapy in Castration Resistant Prostate Cancer

NCT03734653 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 18-0821.cc
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-labeled, single-arm, interventional pilot study. It is being done to determine the feasibility of the administration of transdermal testosterone alternating with enzalutamide, as well as the safety and efficacy.

Conditions

Prostate Cancer; Castration-Resistant Prostate Cancer

Keywords

Square Wave Testosterone Therapy; Androgen Deprivation Therapy; Transdermal Testosterone; Feasibility Study

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Administration of Transdermal Testosterone Alternating with Enzalutamide

  This study will be considered feasible if at least 50% of patients approached for participation enroll and if at least 50% of patients that initiate therapy do not withdraw consent for participation.

  Study start date to study end date, up to 12 months, or until patient death

Secondary Outcomes (20)

• Safety of the Administration of Transdermal Testosterone Alternating with Enzalutamide

  Study start date to study end date, up to 12 months, or until patient death

• Prostate Specific Antigen (PSA) Response Rate

  Study start date to study end date, up to 12 months, or until patient death

• Time to Radiographic Progression

  Study start date to study end date, up to 12 months, or until patient death

• Time to Radiographic Progression

  Study start date to study end date, up to 12 months, or until patient death

• Time to PSA Progression

  Study start date to study end date, every four weeks, up to 12 months, or until patient death

Study Arms (1)

Square Wave Testosterone Therapy + SOC

EXPERIMENTAL

All patients will receive transdermal testosterone. All patients will also receive standard of care enzalutamide. Patients will alternate between the two therapies.

Drug: Transdermal Testosterone; Drug: Standard of Care, Enzalutamide

Interventions

Transdermal Testosterone DRUG

Patients will be prescribed 2 packets of testosterone gel 1% containing 50mg per packet to apply transdermally daily.

Square Wave Testosterone Therapy + SOC

Standard of Care, Enzalutamide DRUG

Patients will take four 40mg capsules of enzalutamide for a total daily dose of 160mg.

Square Wave Testosterone Therapy + SOC

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision to sign and date the consent form
• Male and age \> or = 18 years old
• Stated willingness to comply with all study procedures and be available for the duration of the study
• Histologically or cytologically proven adenocarcinoma of the prostate
• Ongoing ADT for prostate cancer with a GnRH analogue/antagonist or bilateral orchiectomy for at least 6 months prior to day 1
• Patients on a first generation anti-androgen (e.g. bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continued PSA progression
• Serum testosterone level \<50ng/dL at the screening visit
• Progressive disease at screening as defined by one or more of the following criteria:
• PSA progression: minimum of 2 rising values within an interval of \>1 week between values. And a value at screening of \>1ng/mL
• Soft tissue progression on CT or MRI based on RECIST 1.1 criteria or progression of bone disease according to PCWG3 criteria
• Patients worst pain in the last 24 hours must rank less than 4 on a 0-10 scale and patients cannot be on daily narcotic medications to treat cancer-related pain. This assessment must occur within the screening window and be documented in the patient's medical record.
• Acceptable Clinical laboratory values at Screening Visit which include:
• Absolute neutrophil count ≥ 1000/uL; platelet count ≥ 100,000/uL, hemoglobin ≥ 8g/dL
• Total bilirubin ≤ 1.5xULN (unless documented Gilbert's); alanine aminotransferase or aspartate aminotransferase ≤ 2.5xULN
• Creatinine ≤ 2mg/dL

You may not qualify if:

• Requires urinary catheterization for voiding due to obstruction secondary to prostatic enlargement that is well documented to be due to prostate cancer or benign prostatic hyperplasia
• Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone due to a potential tumor flare (e.g. high-risk bone lesions which may result in fracture or spinal cord compression
• Clinically significant cardiovascular disease as evidenced by any of the following:
• Myocardial infarction with 6 months of screening
• uncontrolled angina within 3 months of screening
• NYHA class 3 or 4 congestive heart failure
• clinically significant ventricular arrhythmia
• Mobitz II/Second degree/or 3rd degree heart block without a pacemaker in place; uncontrolled HTN (systolic \>180mmHg or diastolic \>105mmHg at screening
• Previous exposure to a second-generation anti-androgen i.e enzalutamide or apalutamide
• Received investigational agent within 2 weeks of screening
• Therapy with antineoplastic systemic chemotherapy or biological therapy within 2 weeks of screening
• Radiation therapy within 2 weeks of screening
• History of a prior malignancy (excluding an adequately treated basal or squamous cell skin cancer, superficial bladder cancer, or a cancer in situ) within 5 years prior to study enrollment
• History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agent
• Known or suspected brain metastasis or active leptomeningeal disease

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Cancer League of Colorado: collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Standard of Care; enzalutamide

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)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Laura Graham, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a longitudinal pilot, single arm, interventional study.

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 8, 2018
• Study Start: January 18, 2019
• Primary Completion: August 14, 2024
• Study Completion: September 30, 2025
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Between 6 and 36 months post publication
• Access Criteria: Sound proposal with IRB approval. Analyses can be be in keeping with the submitted protocol. This will be reviewed internally for use.

Locations

US (1)