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