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

NCT ID: NCT06305598

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

Conditions: Official terms:
Carcinoma
Prostatic Neoplasms
Methyltestosterone
Leuprolide
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Biopsy
Description: Undergo biopsy
Arm group label: Treatment (Bipolar androgen therapy)

Other name: BIOPSY_TYPE

Other name: Bx

Intervention type: Procedure
Intervention name: Bone Scan
Description: Undergo bone scan
Arm group label: Treatment (Bipolar androgen therapy)

Other name: Bone Scintigraphy

Intervention type: Procedure
Intervention name: Computed Tomography
Description: Undergo CT scan
Arm group label: Treatment (Bipolar androgen therapy)

Other name: CAT

Other name: CAT Scan

Other name: Computed Axial Tomography

Other name: Computerized Axial Tomography

Other name: Computerized axial tomography (procedure)

Other name: Computerized Tomography

Other name: Computerized Tomography (CT) scan

Other name: CT

Other name: CT Scan

Other name: tomography

Intervention type: Drug
Intervention name: Leuprolide Acetate
Description: Given SC
Arm group label: Treatment (Bipolar androgen therapy)

Other name: A-43818

Other name: Abbott 43818

Other name: Abbott-43818

Other name: Carcinil

Other name: Depo-Eligard

Other name: Eligard

Other name: Enanton

Other name: Enantone

Other name: Enantone-Gyn

Other name: Ginecrin

Other name: LEUP

Other name: Leuplin

Other name: Leuprorelin Acetate

Other name: Lucrin

Other name: Lucrin Depot

Other name: Luprodex Depot

Other name: Lupron

Other name: Lupron Depot

Other name: Lupron Depot-3 Month

Other name: Lupron Depot-4 Month

Other name: Lupron Depot-Ped

Other name: Lutrate

Other name: Procren

Other name: Procrin

Other name: Prostap

Other name: TAP-144

Other name: Trenantone

Other name: Uno-Enantone

Other name: Viadur

Intervention type: Procedure
Intervention name: Magnetic Resonance Imaging
Description: Undergo MRI
Arm group label: Treatment (Bipolar androgen therapy)

Other name: Magnetic Resonance

Other name: Magnetic Resonance Imaging (MRI)

Other name: Magnetic resonance imaging (procedure)

Other name: Magnetic Resonance Imaging Scan

Other name: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

Other name: MR

Other name: MR Imaging

Other name: MRI

Other name: MRI Scan

Other name: MRIs

Other name: NMR Imaging

Other name: NMRI

Other name: Nuclear Magnetic Resonance Imaging

Other name: sMRI

Other name: Structural MRI

Intervention type: Other
Intervention name: Survey Administration
Description: Ancillary studies
Arm group label: Treatment (Bipolar androgen therapy)

Intervention type: Drug
Intervention name: Testosterone Cypionate
Description: Given IM
Arm group label: Treatment (Bipolar androgen therapy)

Other name: depAndro

Other name: Depo-Testosterone

Other name: Depotest

Other name: Depovirin

Other name: Pertestis

Other name: Virilon

Summary: 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.

Detailed description: PRIMARY OBJECTIVE: I. To determine the influence of bipolar androgen therapy (BAT) on androgen receptor (AR) activity in patients with metastatic castration-resistant prostate cancer (mCRPC). SECONDARY OBJECTIVES: - To determine the clinical efficacy and safety of BAT in patients with mCRPC. - To determine the change in fatigue and quality of life in patients receiving BAT. OUTLINE: Patients receive testosterone intramuscularly (IM) on day 1 of each cycle. Cycles repeat every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also continue to receive standard of care leuprolide acetate subcutaneously (SC) per their standard schedule. Patients undergo computed tomography (CT) scan, bone scan and may undergo magnetic resonance imaging and tumor biopsy throughout the study. After completion of study treatment, patients follow up at 30 days and every 3 months for up to 2 years.

Criteria for eligibility:
Criteria:
Inclusion 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 Exclusion Criteria: - 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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Roswell Park Cancer Institute

Address:
City: Buffalo
Zip: 14263
Country: United States

Status: Recruiting

Contact:
Last name: Gurkamal S. Chatta

Phone: 716-845-3117
Email: Gurkamal.Chatta@RoswellPark.org

Investigator:
Last name: Gurkamal S. Chatta
Email: Principal Investigator

Start date: December 15, 2024

Completion date: December 15, 2027

Lead sponsor:
Agency: Roswell Park Cancer Institute
Agency class: Other

Source: Roswell Park Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06305598

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