RECRUITING

Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer

Conditions

Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Stage IVB Prostate Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression.

Official Title

Bipolar Androgen Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Quick Facts

Study Start:2024-12-15

Study Completion:2027-12-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06305598

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥ 18 years of age * Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Histologically confirmed carcinoma of the prostate * Progressing on continuous androgen ablative therapy (either surgical castration or LHRH agonist) * Documented castrate level of blood testosterone (\< 50 ng/dL) * Patients must have progressed on prior treatment with at least one Androgen Receptor Signaling Inhibitors (ARSI) and at least one chemotherapy (by prostate specific antigen \[PSA\] criteria or radiographically) * Have biopsiable disease (a fresh biopsy is not required at baseline if adequate archival tissue is available) * Absolute neutrophil count: ≥1,200/µL * Platelets: ≥ 100,000/µL * Total bilirubin: ≤ 1.2 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]): ≤ 3 × institutional ULN * Creatinine clearance (CrCl) \> 50 mL/min (Cockcroft-Gault equation) * Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure	* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * Greater than 5 sites of visceral disease in lung or liver (nonspecific lung nodules ≤ 1 cm in diameter is permitted) * Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g., femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction) * Active uncontrolled infection, including known history of acquired immunodeficiency syndrome (AIDS) or hepatitis B or C * Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule * Prior history of a thromboembolic event within the last 12 months and not currently on systemic anticoagulation * Hematocrit \> 50%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure (per Endocrine Society Clinical Practice Guidelines) * Evidence of serious and/or unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study * Known allergy to testosterone cypionate or any of its excipients * Unwilling or unable to follow protocol requirements * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug

Inclusion Criteria

Exclusion Criteria

* Age ≥ 18 years of age
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Histologically confirmed carcinoma of the prostate
* Progressing on continuous androgen ablative therapy (either surgical castration or LHRH agonist)
* Documented castrate level of blood testosterone (\< 50 ng/dL)
* Patients must have progressed on prior treatment with at least one Androgen Receptor Signaling Inhibitors (ARSI) and at least one chemotherapy (by prostate specific antigen \[PSA\] criteria or radiographically)
* Have biopsiable disease (a fresh biopsy is not required at baseline if adequate archival tissue is available)
* Absolute neutrophil count: ≥1,200/µL
* Platelets: ≥ 100,000/µL
* Total bilirubin: ≤ 1.2 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]): ≤ 3 × institutional ULN
* Creatinine clearance (CrCl) \> 50 mL/min (Cockcroft-Gault equation)
* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
* Greater than 5 sites of visceral disease in lung or liver (nonspecific lung nodules ≤ 1 cm in diameter is permitted)
* Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g., femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction)
* Active uncontrolled infection, including known history of acquired immunodeficiency syndrome (AIDS) or hepatitis B or C
* Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
* Prior history of a thromboembolic event within the last 12 months and not currently on systemic anticoagulation
* Hematocrit \> 50%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure (per Endocrine Society Clinical Practice Guidelines)
* Evidence of serious and/or unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
* Known allergy to testosterone cypionate or any of its excipients
* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug

Contacts and Locations

Principal Investigator

Gurkamal S Chatta

PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Study Locations (Sites)

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

Gurkamal S Chatta, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-15

Study Completion Date2027-12-15

Study Record Updates

Study Start Date2024-12-15

Study Completion Date2027-12-15

Terms related to this study

Additional Relevant MeSH Terms

Castration-Resistant Prostate Carcinoma
Metastatic Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8