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Castration-Resistant Prostate CarcinomaPhase 1NCT06305598

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

A Phase 1 study testing Biopsy, Bone Scan and Computed Tomography in people with Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Biopsy, Bone Scan and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
19 Dec 2024to 9 Mar 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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) (by prostate specific antigen [PSA] criteria or radiographically)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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.

Being tested
Biopsy, Bone Scan, Computed Tomography, Leuprolide Acetate, Magnetic Resonance Imaging
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo biopsy

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • Leuprolide AcetateDrug

    Also called A-43818, Abbott 43818, Abbott-43818, Carcinil

    Given SC

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Survey AdministrationOther

    Ancillary studies

  • Testosterone CypionateDrug

    Also called depAndro, Depo-Testosterone, Depotest, Depovirin

    Given IM

Study groups in NCT06305598
Study groupRoleWhat they receive
Treatment (Bipolar androgen therapy)ExperimentalPatients receive testosterone 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 SC per their standard schedule. Patients undergo CT scan, bone scan and may undergo MRI and tumor biopsy throughout the study.
Receives: Procedure: Biopsy; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Leuprolide Acetate; Procedure: Magnetic Resonance Imaging; Other: Survey Administration; Drug: Testosterone Cypionate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Androgen receptor (AR) activity

    Assessed with spatial transcriptomic profiling using the well-validated Nelson 10 genes signature AR score. Will be summarized by timepoint using the mean and standard deviation, and graphically using dot-plots. The mean pre/post-intervention levels will be compared using a one-sided paired t-test (expected increase); with the effect summarized using the mean difference and fold change.

    Measured: Up to 2 years after end of treatment/progression

Secondary outcomes (10)

  1. Incidence of adverse events

    Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Up to 30 days after end of treatment or progression

  2. Incidence of serious adverse events

    Using the NCI CTCAE version 5.0.

    Measured: Up to 30 days after end of treatment or progression

  3. Prostate specific antigen (PSA) 50

    Defined as the proportion of patients with a >=50% reduction in PSA from the maximal PSA level achieved during the treatment. Will be summarized using frequencies and relative frequencies.

    Measured: Up to 2 years after end of treatment/progression

  4. Measurable disease response

    Will be summarized using frequencies and relative frequencies.

    Measured: Up to 2 years after end of treatment/progression

  5. Progression free survival

    Will be summarized using standard Kaplan-Meier methods, where the medians will be estimated with 95% confidence intervals (CIs).

    Measured: From day 1 of treatment to the date when the first site of disease is found to progress, assessed up to 2 years after end of treatment/progression

  6. Overall survival

    Will be summarized using standard Kaplan-Meier methods, where the medians will be estimated with 95% CIs.

    Measured: From the time of initiation of treatment until death from any cause, assessed up to 2 years after end of treatment/progression

  7. Assess Quality of life

    Using the FACIT-F.he FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue . Comparisons will be made between pre- and post-treatment using a paired t-test.

    Measured: Up to 2 years after end of treatment/progression

  8. Assess Quality of Life

    A self-reported 36 item survey (SF-36) of patient health where higher scores indicated better health related quality of life

    Measured: Up to 2 years after end of treatment/progression

  9. Assess Fatigue

    Using the FACIT-F (FACIT Fatigue Scale) the FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue

    Measured: Up to 2 years after end of treatment/progression

  10. Assess change in Fatigue

    Assess changes in Fatigue using the SF-36 (Short Form Health Survey) A self reported 36 item survey where lower scores indicate greater fatigue.

    Measured: Up to 2 years after end of treatment/progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start19 Dec 2024
  3. Primary completion9 Mar 2026
  4. Study completion9 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06305598
Sponsor's protocol ID
I-3298823
Other IDs
NCI-2024-01390, I-3298823
Status last verified
Aug 2026
First submitted
5 Mar 2024
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biopsy, Bone Scan and Computed Tomography in people with Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Androgen receptor (AR) activity (time frame: Up to 2 years after end of treatment/progression). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06305598.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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