Metastatic Castration-resistant Prostate CancerPhase 2NCT07142551
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
A Phase 2 study testing Testosterone cypionate, Luteinizing hormone-releasing hormone (LHRH) analogue and Darolutamide in people with Metastatic Castration-resistant Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Testosterone cypionate, Luteinizing hormone-releasing hormone (LHRH) analogue and Darolutamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2026to 1 Jun 2034
- Phase
- Phase 2
- 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
- Performance status ≤2.
- Documented histologically confirmed adenocarcinoma of the prostate.
- Baseline PSA ≥1.0 ng/ml.
- No prior androgen deprivation therapy (i.e. surgical castration LHRH agonist, LHRH antagonist) as treatment for biochemically recurrent or metastatic disease (may have received neoadjuvant, concurrent and/or adjuvant AD therapy in the context of definitive radiation therapy if it was administered ≥ 1 year prior to recurrence).
- No prior treatment with ARPI (abiraterone, enzalutamide, darolutamide) for biochemically recurrent or metastatic prostate cancer. Neoadjuvant, concurrent and/or adjuvant ARPI +/- ADT is permitted if given in the context of definitive radiation therapy if it was administered ≥ 1 year prior to development of metastatic disease.
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- Prior focal radiation treatment (e.g. SABR, Cyberknife) for oligometastatic disease is permitted if > 6 months. Patients must have evidence of metastatic disease in non-irradiated sites to be eligible for study.
- Evidence of rising PSA on two successive dates > 2 weeks apart.
- Evidence of metastatic disease on CT scan or bone scan performed with six weeks of screening.
- Patients with bone pain due to prostate cancer are eligible for trial but must be pain free at the end of the 6-month lead-in phase to be eligible to receive subsequent BAT.
- Patients with soft tissue lesions amenable to biopsy must agree to baseline and 6 months tumor biopsies to enroll in study.
- Acceptable liver function:
- Bilirubin < 2.5 times institutional upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) < 2.5 times ULN
- Acceptable renal function:
- Serum creatinine < 2.5 times ULN
- Acceptable hematologic status:
- Absolute neutrophil count (ANC) > 1000 cells/mm3 (1.0 ×109/L)
- Platelet count > 100,000 platelet/mm3 (100 ×109/L)
- Hemoglobin > 9 g/dL.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- No prior treatment with chemotherapeutic regimens allowed.
- No prior treatment with Pluvicto or other PSMA-targeted agents is allowed.
- No prior treatment with Androgen Receptor targeted investigational agents is permitted.
- 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.
- Evidence of disease that, in the opinion of the investigator, would put the patient at risk from testosterone therapy (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).
- Requires urinary self-catheterization for voiding due to obstruction secondary to prostatic enlargement well-documented to be due to prostate cancer or benign prostatic hyperplasia (BPH). Patients with indwelling Foley or suprapubic catheter for obstructive symptoms are eligible.
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- Active uncontrolled infection.
- Any condition or mental impairment that may compromise the ability to give informed consent, patient's safety or compliance with study requirements as determined by the investigator.
- Patients receiving anticoagulation therapy with Warfarin or Coumadin are not eligible for study. Patients on non-coumadin anticoagulants (Lovenox, Eliqis, Xarelto, etc.) are eligible for study. Patients on Coumadin who can be transitioned to non-coumadin anticoagulants prior to starting study treatments will be eligible.
- Hematocrit >51%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure [per Endocrine Society Clinical Practice Guidelines (34)]
- Patients allergic to sesame seed oil or cottonseed oil are excluded.
- Major surgery as determined by the treating physician within 3 weeks before screening, or has not fully recovered from prior surgery (i.e., unhealed wound). Note: subjects with planned procedures (minor surgery with local anesthesia), colonoscopy under anesthesia may participate.
- Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within the last five years prior to enrollment in the study.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21205
Samuel Denmeade, MD, 410-733-3232, denmesa@jhmi.edu
About this study
Official title: Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response Via Modulation of ANdrogen Receptor (the SPIDERMAN Trial)
The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alternating therapy.
Read the detailed description
This research is being done to determine if alternating high dose testosterone and prevent the development of resistance to hormone therapy. It is also being done to determine if this alternating therapy can decease the side effects of hormone therapy and improve the participant's quality of life.
Right now, patients who develop metastatic prostate cancer are treated with medications that block testosterone effects as first-line therapy. Eventually, the testosterone blocking therapies become ineffective and the tumor begins to grow. The investigaors call this phase of the disease castrater-resistant prostate cancer (CRPC). Previous research has shown that prostate cancer cells can eventually adapt to low testosterone conditions produced by hormone therapy and begin to grow again. The investigators have learned that these resistant prostate cancer cells can killed by high levels of testosterone followed by a rapid drop to low testosterone levels. The investigators call this treatment bipolar androgen therapy (BAT) because the investigators are going from the polar extremes of high and low testosterone in the blood every 28 days. The investigators have tested this idea in previous studies by giving injections of high doses of testosterone to patients with CRPC. In these trials, the investigators saw that BAT was safe. BAT produced decreases in PSA levels and decreases in tumor size in some patients. After treatment with BAT, many patients had an improved response to the testosterone-blocking drug enzalutamide. The drug used in this study, darolutamide, is similar to enzalutamide. Both drugs are considered to be antiandrogens that block effects of testosterone within the prostate cancer cells.
The investigators also did a study called the BATMAN study in patients with mHSPC. These patients received alternating therapy with high dose testosterone and ADT as first line therapy. In this study, alternating testosterone and ADT was found to be safe. In this study, more patients remained sensitive to hormone therapy after 18 months than the investigators would have expected with ADT alone.
In this study, the investigators would like to see if improvement on these results and decrease hormonal side effects when the investigators give testosterone in sequence with darolutamide.
- Being tested
- Testosterone cypionate, Luteinizing hormone-releasing hormone (LHRH) analogue, Darolutamide
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone cypionateDrug
Also called Depo-Testosterone
Intermittent intramuscular testosterone cypionate (T) at a dose of 400 mg every 4 weeks.
Luteinizing hormone-releasing hormone (LHRH) analogueDrug
Also called Trelstar, Eligard, Lupron, Degarelix
Eligible patients will initiate combined androgen deprivation therapy (ADT) with an LHRH agonist or antagonist (e.g. Eligard, Zoladex, Lupron, Orgovyx) in combination with standard dose darolutamide (600 mg twice daily) for a total of 6 months.
DarolutamideDrug
Also called Nubeqa
600 mg twice daily during the lead-in phase and on darolutamide cycle.
| Study group | Role | What they receive |
|---|---|---|
| Lead-In Phase - ADT with an LHRH agonist or antagonist | Experimental | Eligible patients will initiate combined androgen deprivation therapy (ADT) with an LHRH agonist or antagonist (e.g. Eligard, Zoladex, Lupron, Orgovyx) in combination with standard dose darolutamide (600 mg twice daily) for a total of 6 months. After this initial "lead-in" phase, patients who have clinical or radiographic progression or do not have at least a ≥50% decline in PSA will remain on combined androgen deprivation and discontinue study. Receives: Drug: Luteinizing hormone-releasing hormone (LHRH) analogue; Drug: Darolutamide |
| Bipolar Androgen-based Therapy (BAT) Cycle | Experimental | Patients with ≥50% decline in PSA will discontinue combined androgen deprivation and will receive intermittent intramuscular testosterone cypionate (T) at a dose of 400 mg every 4 weeks for a total of 3 injections while on a BAT cycle (12 weeks). Receives: Drug: Testosterone cypionate |
| Darolutamide Cycle | Experimental | Patient will proceed to a cycle off BAT and start darolutamide alone at 600 mg twice daily for 12 weeks. Patients will continue with alternating cycles of BAT or darolutamide (without ADT) until clinical or radiographic progression. Receives: Drug: Darolutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects free of Clinical or radiographic free progression
Percent of subjects are free of clinical or radiographic progression at 24 months from initiation of treatment
Measured: 24 months from Day 1 (start of treatment)
Secondary outcomes (6)
Percent of patients who achieve Complete PSA response at end of in lead-in phase
Percent of patients who achieve a complete PSA response (i.e. serum PSA <0.2 ng/ml) at end of in lead-in phase.
Measured: 6 months from Day 1 (start of treatment)
Percent of patients who achieve Complete PSA response with darolutamide treatment
Percent of patients who achieve a complete PSA response (i.e. serum PSA <0.2 ng/ml) over the course of treatment with darolutamide.
Measured: 36 months from Day 1 (start of treatment)
Number of patients with Clinical or Radiographic progression free survival
Number of patients with clinical or radiographic progression free survival while on the study.
Measured: 6 years from Day 1 (start of treatment)
Overall Survival
Number of months from the start of study treatment in the lead-in phase to death due to any cause, will be summarized using Kaplan-Meier method
Measured: 6 years from Day 1 (start of treatment)
Objective Response to darolutamide
Number of patients who have complete response or partial response according to RECIST 1.1 criteria, among those with measurable disease at baseline, with darolutamide treatment following BAT.
Measured: 1 year from Day 1 (start of treatment)
Response in patients with high volume (CHAARTED criteria) vs. low volume disease
Number of patients who have complete response or partial response according to RECIST 1.1 criteria, among those with measurable disease at baseline, with high volume disease vs those with low volume disease.
Measured: 3 years from Day 1 (start of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start9 Mar 2026
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Samuel Denmeade, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142551
- Sponsor's protocol ID
- J2564
- Other IDs
- IRB00509292
- Status last verified
- Mar 2026
- First submitted
- 19 Aug 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response Via Modulation of ANdrogen Receptor (the SPIDERMAN Trial)
- ClinicalTrials.gov ID
- NCT07142551
- Acronym / sponsor ID
- J2564
- Keywords
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2034 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alternating therapy.
Detailed description
This research is being done to determine if alternating high dose testosterone and prevent the development of resistance to hormone therapy. It is also being done to determine if this alternating therapy can decease the side effects of hormone therapy and improve the participant's quality of life.
Right now, patients who develop metastatic prostate cancer are treated with medications that block testosterone effects as first-line therapy. Eventually, the testosterone blocking therapies become ineffective and the tumor begins to grow. The investigaors call this phase of the disease castrater-resistant prostate cancer (CRPC). Previous research has shown that prostate cancer cells can eventually adapt to low testosterone conditions produced by hormone therapy and begin to grow again. The investigators have learned that these resistant prostate cancer cells can killed by high levels of testosterone followed by a rapid drop to low testosterone levels. The investigators call this treatment bipolar androgen therapy (BAT) because the investigators are going from the polar extremes of high and low testosterone in the blood every 28 days. The investigators have tested this idea in previous studies by giving injections of high doses of testosterone to patients with CRPC. In these trials, the investigators saw that BAT was safe. BAT produced decreases in PSA levels and decreases in tumor size in some patients. After treatment with BAT, many patients had an improved response to the testosterone-blocking drug enzalutamide. The drug used in this study, darolutamide, is similar to enzalutamide. Both drugs are considered to be antiandrogens that block effects of testosterone within the prostate cancer cells.
The investigators also did a study called the BATMAN study in patients with mHSPC. These patients received alternating therapy with high dose testosterone and ADT as first line therapy. In this study, alternating testosterone and ADT was found to be safe. In this study, more patients remained sensitive to hormone therapy after 18 months than the investigators would have expected with ADT alone.
In this study, the investigators would like to see if improvement on these results and decrease hormonal side effects when the investigators give testosterone in sequence with darolutamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lead-In Phase - ADT with an LHRH agonist or antagonist | Experimental | Drug: Luteinizing hormone-releasing hormone (LHRH) analogue, Drug: DarolutamideEligible patients will initiate combined androgen deprivation therapy (ADT) with an LHRH agonist or antagonist (e.g. Eligard, Zoladex, Lupron, Orgovyx) in combination with standard dose darolutamide (600 mg twice daily) for a total of 6 months. After this initial "lead-in" phase, patients who have clinical or radiographic progression or do not have at least a ≥50% decline in PSA will remain on combined androgen deprivation and discontinue study. |
| Bipolar Androgen-based Therapy (BAT) Cycle | Experimental | Drug: Testosterone cypionatePatients with ≥50% decline in PSA will discontinue combined androgen deprivation and will receive intermittent intramuscular testosterone cypionate (T) at a dose of 400 mg every 4 weeks for a total of 3 injections while on a BAT cycle (12 weeks). |
| Darolutamide Cycle | Experimental | Drug: DarolutamidePatient will proceed to a cycle off BAT and start darolutamide alone at 600 mg twice daily for 12 weeks. Patients will continue with alternating cycles of BAT or darolutamide (without ADT) until clinical or radiographic progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥ 18 years
- Performance status ≤2.
- Documented histologically confirmed adenocarcinoma of the prostate.
- Baseline PSA ≥1.0 ng/ml.
- No prior androgen deprivation therapy (i.e. surgical castration LHRH agonist, LHRH antagonist) as treatment for biochemically recurrent or metastatic disease (may have received neoadjuvant, concurrent and/or adjuvant AD therapy in the context of definitive radiation therapy if it was administered ≥ 1 year prior to recurrence).
Key exclusion criteria (14 listed)
- No prior treatment with chemotherapeutic regimens allowed.
- No prior treatment with Pluvicto or other PSMA-targeted agents is allowed.
- No prior treatment with Androgen Receptor targeted investigational agents is permitted.
- 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.
- Evidence of disease that, in the opinion of the investigator, would put the patient at risk from testosterone therapy (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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone cypionateAlso: Depo-TestosteroneIntermittent intramuscular testosterone cypionate (T) at a dose of 400 mg every 4 weeks. | Drug | Bipolar Androgen-based Therapy (BAT) Cycle |
| Luteinizing hormone-releasing hormone (LHRH) analogueAlso: Trelstar, Eligard, Lupron, DegarelixEligible patients will initiate combined androgen deprivation therapy (ADT) with an LHRH agonist or antagonist (e.g. Eligard, Zoladex, Lupron, Orgovyx) in combination with standard dose darolutamide (600 mg twice daily) for a total of 6 months. | Drug | Lead-In Phase - ADT with an LHRH agonist or antagonist |
| DarolutamideAlso: Nubeqa600 mg twice daily during the lead-in phase and on darolutamide cycle. | Drug | Darolutamide Cycle, Lead-In Phase - ADT with an LHRH agonist or antagonist |
Primary outcome
Percent of subjects free of Clinical or radiographic free progression
Time frame: 24 months from Day 1 (start of treatment)
Percent of subjects are free of clinical or radiographic progression at 24 months from initiation of treatment
6 secondary outcomes
Percent of patients who achieve Complete PSA response at end of in lead-in phase
Time frame: 6 months from Day 1 (start of treatment)
Percent of patients who achieve Complete PSA response with darolutamide treatment
Time frame: 36 months from Day 1 (start of treatment)
Number of patients with Clinical or Radiographic progression free survival
Time frame: 6 years from Day 1 (start of treatment)
Overall Survival
Time frame: 6 years from Day 1 (start of treatment)
Objective Response to darolutamide
Time frame: 1 year from Day 1 (start of treatment)
Response in patients with high volume (CHAARTED criteria) vs. low volume disease
Time frame: 3 years from Day 1 (start of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel Denmeade, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone cypionate, Luteinizing hormone-releasing hormone (LHRH) analogue and Darolutamide in people with Metastatic Castration-resistant Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 21 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 11 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Rana Sullivan, RN (410-614-6337, tomalra@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of subjects free of Clinical or radiographic free progression (time frame: 24 months from Day 1 (start of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2026.