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Hormone Sensitive Prostate CancerPhase 2NCT04126070

Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors

A Phase 2 study testing Androgen Deprivation Therapy, Nivolumab and Docetaxel in people with Hormone Sensitive Prostate Cancer and Prostate Adenocarcinoma, run by Xiao X. Wei, MD at 6 sites in United States.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This research study is studying a combination of hormonal therapy, chemotherapy, and immunotherapy as a possible treatment for metastatic hormone-sensitive prostate cancer. The names of the study drugs involved in this study are: Androgen deprivation therapy (ADT) with a drug of your physician's choice. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Androgen Deprivation Therapy, Nivolumab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
6 sitesUnited States
Study dates
11 May 2020to 30 Oct 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Newly diagnosed histologically confirmed prostate adenocarcinoma within 6 months prior to study registration with evidence of high-volume distant metastasis on conventional imaging
  • Distant metastasis is defined by non-regional lymph node(s) metastasis (M1a), bone metastasis (M1b), and/or other site(s) of metastatic disease (M1c).
  • Conventional imaging consists of CT, MRI or radionuclide bone scan
  • High volume of disease is defined by presence of four or more bone lesions with at least one beyond the vertebral bodies or pelvis or any site of visceral metastasis.
  • Age ≥18 years
  • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
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  • Subjects with ECOG performance status of 2 are only eligible if the performance status decline is attributed to metastatic prostate cancer
  • Serum PSA > 4.0 ng/mL before initiation of ADT
  • Serum testosterone > 100 ng/dL before initiation of ADT
  • Subjects whose testosterone level is unknown before initiation of ADT may be allowed after discussion with Sponsor-Investigator.
  • Grade ≤ 1 peripheral neuropathy, defined as asymptomatic or paresthesia and/or decreased deep tendon reflexes is allowed.
  • Subjects must have adequate organ and marrow function as defined below:
  • Absolute neutrophil count ≥1,500 /mcL
  • Platelets ≥100,000 /mcL
  • Total bilirubin ≤1.5 × institutional upper limit of normal. Exception: Subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology) may be allowed after consultation with treating physician
  • AST(SGOT) and ALT(SGPT) ≤2.5 × institutional upper limit of normal. Exception: ≤5 x institutional upper limit of normal in subjects with liver metastasis
  • Creatinine (Cr) and creatinine clearance (CrCl) Cr <1.6 mg/dL or CrCl ≥30 mL/min; CrCl should be calculated using the Cockcroft-Gault formula: CrCl (mL/min) = (140-Age) x Body weight (Kg)/72 x Serum creatinine (mg/dL)
  • PT, INR and PTT ≤ 1.5 x institutional upper limit of normal. Exception: Subjects who are on a stable regimen of therapeutic anticoagulation for an appropriate clinical indication may be enrolled
  • Availability of adequate baseline prostate biopsy tissue for integral biomarker analysis and correlative studies:
  • Sources of tumor tissue allowed are (1) prostate biopsy, (2) transurethral resection of the prostate tissue (TURP) , (3) trans urethral resection of bladder tumor tissue (TURBT) with contiguous spread of prostate cancer to the bladder, and (4) metastatic biopsy tissue excluding bone and lymph node metastases (e.g. lung or liver biopsies are acceptable).
  • For OncoPanel, submit at least one (1) H\&E slide and ten (10) 5-micron thick serially sectioned unstained formalin-fixed paraffin-embedded (FFPE) slides. Biopsy should contain at least 20% tumor involvement with the highest Gleason score(s). If requested tissue is unavailable, a lower number of 4-micron or 5- micron slides and/or slides containing lower tumor involvement may be accepted after discussion with the Sponsor-Investigator.
  • For ImmunoProfile, submit at least one (1) H\&E slide and one (1) 5-micron thick serially sectioned unstained, freshly cut, FFPE slide. Biopsy should contain at least 50% tumor involvement with the highest Gleason score(s). If requested tissue is unavailable, a 5-micron slide containing lower tumor involvement may be accepted after discussion with the study Sponsor-Investigator.
  • Submission of one (1) H\&E slide and at least one (1) FFPE tissue core block with at least 3mm2 tumor area with the highest Gleason score is an acceptable alternative to unstained FFPE slides.
  • Subjects who have insufficient baseline prostate biopsy tissue for OncoPanel analysis but have baseline metastatic biopsy tissue available may have OncoPanel analysis performed using metastatic biopsy tissue. Successful OncoPanel testing (but not ImmunoProfile) of metastatic biopsy tissue is acceptable from any source including lymph node or bone, after discussion with the study Sponsor- Investigator.
  • For Exploratory Correlative Studies, at least 1 tissue core block (preferred) or one (1) H\&E slide and twelve (12) 5-micron thick FFPE slides with unstained, freshly cut, serial sections from biopsy cores containing at least 20% tumor involvement with the highest Gleason score(s) will be requested, if available.
  • Tissue should be submitted with redacted pathology report.
  • Successful OncoPanel and ImmunoProfile biomarker analysis for allocation into a study cohort during pre-screening
  • Subjects whose tumors harbor somatic or germline homozygous deletions and/or deleterious mutations in a DDR gene using OncoPanel will be assigned to Cohort 1, regardless of ImmunoProfile results
  • DDR genes include and are not limited to BRCA2, ATM, CHEK2, BRCA1, PALB2, RAD51D, ATR, NBN, PMS2, GEN1, MLH1, MSH2, MSH6, RAD51C, MRE11A, BRIP1, FAM175A, and CDK12
  • Deleterious mutations are defined as loss of function, splice site, nonsense, or frameshift mutations, and determination will be made between DFCI molecular pathology and study Sponsor-Investigator
  • Tumors identified as mismatch repair deficient (MMR-d) or microsatellite instability high (MSI-H) will also be included in Cohort 1
  • Patients with germline DDRD or MMR-d/MSI-H (Lynch Syndrome) or tumors with DDRD or MMR-d/MSI-H identified in another CLIAcertified laboratory (e.g., Foundation Medicine) using prostate or metastatic tissue may be assigned to Cohort 1 after discussion with the Sponsor-Investigator. If archival tissue is available, it will be requested for OncoPanel testing; however, results will not influence eligibility.
  • Subjects whose tumors are PD-L1 positive and/or CD8+ T cell inflamed using ImmunoProfile without the presence of DDRD will be assigned to Cohort 2
  • PD-L1 positivity will be defined as Combined Positive Score (CPS) ≥ 1, which is the number of PD-L1 staining cells (e.g., tumor cells, immune cells) divided by the total number of tumor cells, multiplied by 100
  • CD8+ T cell inflammation will be defined as CD8+ T cell density ≥ 200, which is the number of CD8+ cells divided by the surface area of a region of interest (mm2)
  • Subjects whose tumors do not harbor DDRD and are PD-L1 negative with low CD8+ T cell infiltration will be assigned to Cohort 3
  • Subjects whose prescreening is unsuccessful for cohort allocation or whose biomarker status matches that of a filled cohort will not be eligible
  • Subjects who underwent successful ImmunoProfile pre-screening but failed OncoPanel pre-screening may be allocated to Cohort 2 or Cohort 3 based on ImmunoProfile results and assuming DDRD negativity, at the discretion of the Sponsor-Investigator.
  • Before one of the study cohorts enrolls 15 of 20 subjects (Cohort 3 is anticipated to complete accrual first), subjects may undergo main study screening when ImmunoProfile and OncoPanel analyses are ongoing, and may proceed to study treatment if they meet all eligibility criteria with the exception that OncoPanel analysis is ongoing. These patients will be allocated into their respective cohort after OncoPanel results return.
  • Willingness to provide leftover metastatic biopsy tissue for correlative studies, if obtained for clinical purposes
  • Based on its mechanism of action and data from animal studies, nivolumab can cause fetal harm. For this reason non-sterilized men who are sexually active with a female partner of childbearing potential treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and for 7 months after last dose of nivolumab administration
  • Adequate contraception includes male condom plus spermicide
  • Not engaging in sexual activity is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
  • Subjects in this study should refrain from sperm donation
  • Ability to understand and the willingness to sign a written informed consent document, or have a legally authorized representative sign on the subject's behalf
  • Men of all races and ethnic groups are eligible for this trial.

Who cannot join

  • Subjects must not have received prior ADT (LHRH analogue +/- antiandrogen), chemotherapy, or immunotherapy for prostate cancer. The following exception is allowed:
  • Subjects who have initiated ADT prior to study registration and are able to complete biomarker pre-screening, cohort allocation, and start C1D1 study chemoimmunotherapy ≤120 days from initiation of ADT are allowed
  • The 120-day window commences at the start of either the antiandrogen agent or LHRH analogue, whichever is earlier
  • Antiandrogens (e.g., bicalutamide or flutamide) may be used in addition to LHRH analogue ≤60 days before initiation of LHRH analogue to cover the testosterone surge associated with certain LHRH agonists but must be discontinued prior to study registration
  • Second-generation hormonal agents (e.g., abiraterone acetate) are not allowed
  • Subjects must not have undergone prostatectomy
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  • Prostate radiation is allowed before or after study enrollment and may be delivered concurrently with study chemoimmunotherapy, per provider discretion, assuming adequate prostate biopsy tissue is collected before prostatic radiation
  • Metastasis-directed radiation is allowed before or after study enrollment and may be delivered concurrently with study chemoimmunotherapy, per provider discretion
  • Subjects who are receiving any other investigational agents
  • Any previous treatment with a PD-1 or PD-L1 inhibitor
  • Subjects 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 AEs
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel (including any drugs formulated with polysorbate 80), nivolumab, or LHRH analogue (e.g., leuprolide, goserelin acetate, degarelix)
  • History of another primary malignancy, except for:
  • Malignancy treated with curative intent and with no known active disease for ≥2 years before the first dose of study treatment and of low potential risk for recurrence
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Major surgical procedure as defined by the Site Investigator within 28 days prior to the first dose of chemoimmunotherapy
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. HIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for nivolumab to be less clinically active in this population. In addition, these subjects are at increased risk of lethal infections when treated with marrow-suppressive chemotherapy
  • History of allogeneic bone marrow or organ transplantation
  • Active or prior documented autoimmune or inflammatory disorders, including= inflammatory bowel disease (e.g., Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, Grave's disease, rheumatoid arthritis, hypophysitis, uveitis, with the following exceptions:
  • Vitiligo or alopecia
  • Hypothyroidism stable on hormone replacement
  • Chronic skin condition that does not require systemic therapy
  • Celiac disease controlled by diet alone
  • Subjects with inactive disease in the last 5 years may be included but only after consultation with the study physician
  • Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg]), or hepatitis C (HCV)
  • Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible
  • Subjects with positive HCV antibody are eligible if polymerase chain reaction is negative for HCV RNA
  • Concurrent or prior use of immunosuppressive medication within 14 days before the first dose of study chemoimmunotherapy, with the following exceptions:
  • Premedication for docetaxel with oral dexamethasone (See Section 5.1)
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intraarticular injection)
  • Systemic corticosteroids at physiologic doses not exceeding 10mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., premedication for iodinated contrast allergy before CT scan)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • The Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21218

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of California, San Diego

    La Jolla, California, 92093

  • University of Wisconsin

    Madison, Wisconsin, 53706

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 2 Multicohort Study of Nivolumab in Combination With Docetaxel and Androgen Deprivation Therapy in Metastatic Hormone Sensitive Prostate Cancer Patients With DNA Damage Repair Defects or Inflamed Tumors

This research study is studying a combination of hormonal therapy, chemotherapy, and immunotherapy as a possible treatment for metastatic hormone-sensitive prostate cancer. The names of the study drugs involved in this study are:

  • Androgen deprivation therapy (ADT) with a drug of your physician's choice. This may include leuprolide (Lupron), goserelin acetate (Zoladex), or degarelix (Firmagon).
  • Docetaxel
  • Nivolumab
Read the detailed description

This research study is a Phase 2 clinical trial. Phase 2 clinical trials test the safety and effectiveness of investigational drug(s) to learn whether the drug(s) work in treating a specific disease. "Investigational" means that the drug(s) are being studied.

The U.S. Food and Drug Administration (FDA) has not approved nivolumab for hormone sensitive prostate cancer. However, nivolumab has been approved for other uses, including for advanced melanoma, lung cancer, head and neck cancer, kidney cancer, and bladder cancer.

The U.S. FDA has not approved docetaxel as a treatment option for hormone sensitive prostate cancer. However, docetaxel is approved for advanced hormone resistant prostate cancer and other cancers. There is also evidence from a high quality, phase 3 randomized clinical trial supporting the use of docetaxel in metastatic hormone sensitive prostate cancer patients who have a high burden of metastasis. Docetaxel is an off-label indication for hormone sensitive prostate cancer.

The U.S. FDA has approved androgen deprivation therapy (ADT) agents, including leuprolide (Lupron), goserelin acetate (Zoladex), or degarelix (Firmagon), as a treatment option for hormone sensitive prostate cancer.

The combination of ADT, also called hormonal therapy, with docetaxel chemotherapy and nivolumab immunotherapy is considered investigational. ADT cuts off the supply of testosterone and is the standard of care for hormone sensitive prostate cancer. The addition of docetaxel chemotherapy has been found to prolong life for prostate cancer patients starting hormonal therapy for the first time for metastatic disease, who also have a large volume of cancer.

Another anti-cancer treatment modality is called immunotherapy. The immune system can kill cells that are recognized as different or dangerous, such as infected cells and cancer cells. Nivolumab is an antibody (a type of human protein) that work to stimulate the body's immune system to recognize and fight cancer cells.

Hormonal therapy and chemotherapy may make cancer cells more recognizable to the immune system, and make cancer cells more susceptible to immunotherapy. The goal of this study is to examine the activity and safety of hormonal therapy combined with docetaxel chemotherapy and nivolumab immunotherapy for hormone sensitive prostate cancer. The study is designed to enrich for patients whose tumors may be more most responsive to this treatment strategy. All patients will receive the same treatment of ADT combined with docetaxel chemotherapy and nivolumab immunotherapy.

Being tested
Androgen Deprivation Therapy, Nivolumab, Docetaxel
Keywords
Hormone Sensitive Prostate Cancer, Prostate Adenocarcinoma, Metastasis Prostate Adenocarcinoma

What participants receive

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

  • Androgen Deprivation TherapyDrug

    Also called Leuprolide, Lupron Depot, Goserelin acetate, Zoladex

    Given per standard care for duration of study. Regimens include Leuprolide (Lupron Depot) intramuscularly every 3 months, Goserelin acetate (Zoladex) subcutaneously every 4 weeks, or degarelix (Firmagon) subcutaneously every month per standard of care.

  • NivolumabDrug

    Given once per every 3 weeks for cycle 1-6 intravenously and then every 4 weeks during subsequent cycles, at predetermined dosage; up to 28 cycles total.

  • DocetaxelDrug

    Also called Taxotere

    Given once every 3 weeks intravenously at pre determined dosage for cycle 1-6.

Study groups in NCT04126070
Study groupRoleWhat they receive
COHORT 1: DNA damage repair defects (DDRD) +/- Inflamed TumorExperimentalAfter the screening procedures confirm participation in the research study. The participant will be given a study calendar for this trial. * Androgen Deprivation Therapy: Given per standard care for duration of study * Nivolumab: Given once per every 3 weeks for cycle 1-6 intravenously and then every 4 weeks during subsequent cycles, at predetermined dosage * Docetaxel: Given once every 3 weeks intravenously at pre-determined dosage for cycle 1-6.
Receives: Drug: Androgen Deprivation Therapy; Drug: Nivolumab; Drug: Docetaxel
COHORT 2: Inflamed Tumor without DNA repair defects (DDRD)ExperimentalAfter the screening procedures confirm participation in the research study. The participant will be given a study calendar for this trial. * Androgen Deprivation Therapy: Given per standard care for duration of study * Nivolumab: Given once per every 3 weeks for cycle 1-6 intravenously and then every 4 weeks during subsequent cycles, at predetermined dosage * Docetaxel: Given once every 3 weeks intravenously at pre-determined dosage for cycle 1-6.
Receives: Drug: Androgen Deprivation Therapy; Drug: Nivolumab; Drug: Docetaxel
COHORT 3: Biomarker NegativeExperimentalAfter the screening procedures confirm participation in the research study. The participant will be given a study calendar for this trial. * Androgen Deprivation Therapy: Given per standard care for duration of study * Nivolumab: Given once per every 3 weeks for cycle 1-6 intravenously and then every 4 weeks during subsequent cycles, at predetermined dosage * Docetaxel: Given once every 3 weeks intravenously at pre-determined dosage for cycle 1-6
Receives: Drug: Androgen Deprivation Therapy; Drug: Nivolumab; Drug: Docetaxel

What is being measured

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

  1. Percentage of Subjects With Prostate Specific Antigen (PSA) Less Than or Equal to 0.2 ng/mL at 7 Months From Start of Chemoimmunotherapy

    Summarized as percentage with 80% two-sided exact binominal confidence interval (CI) for each cohort

    Measured: 7 months from the start of chemoimmunotherapy

Secondary outcomes (7)

  1. Percentage of Subjects With PSA Less Than or Equal to 0.2 ng/mL During the Chemoimmunotherapy Combination

    Measured: From the start of chemoimmunotherapy until the end of treatment or initiation of new anti-cancer therapy, whichever occurred first, for a maximum duration of 2 years.

  2. Best Objective Response Rate in Subjects With Measurable Disease Per RECIST 1,1 Criteria

    Objective response includes "complete response" or "partial response" to the chemoimmunotherapy per RECIST 1.1 criteria.

    Measured: From the start of chemoimmunotherapy until the end of treatment or initiation of new anti-cancer therapy, whichever occurred first, for a maximum duration of 2 years.

  3. Overall Survival Rate at 3-years

    Overall survival rate at 3-years was estimated by the Kaplan-Meier methodology.

    Measured: Time from the start of chemoimmunotherapy to death due to any cause, or censored at date last known alive, up to 3-years

  4. Castration Resistant Disease-free Rate at 12 Months

    Castration resistant disease-free rate at 12 months was estimated from the Kaplan-Meier methodology.

    Measured: Time from the chemoimmunotherapy initiation to date of documented clinical or serological progression with castrate-level testosterone <50 ng/dL, or censored at date of last disease assessment before the start of new anti-cancer therapy, up to 12 months

  5. Clinical Progression Free Rate at 7 Months

    Clinical progression free rate at 7 months will be estimated by the Kaplan-Meier methodology.

    Measured: Time from the chemoimmunotherapy initiation to documented clinical or radiographic progression per RECIST 1.1 criteria, or censored at the date of last disease assessment before the start of new anti-cancer therapy, up to 7 months

  6. Serologic Progression Free Rate at 12 Months

    Serum Prostate-Specific Antigen (PSA) progression was defined as ≥50% increase in serum PSA (with a confirmatory increase with PSA above 4 ng/mL. or with starting a new anti-cancer therapy following PSA 50% increase if no confirmatory increase), with the lowest PSA level (nadir) as reference. Serologic progression free rate at 12 months was estimated by the Kaplan-Meier methodology.

    Measured: Time from the start of chemoimmunotherapy to the date of documented serum PSA progression, or censored at the date of last PSA test before start of new anti-cancer therapy, up to 12 months

  7. Number (%) of Subjects With Grade 3 or Higher Treatment-related Adverse Events (TrAE) as Assessed by CTCAE v5.0

    Treatment-related adverse events (TrAEs) included toxicities deemed possibly, probably, or definitely related to nivolumab or docetaxel.

    Measured: From the start of chemoimmunotherapy until 6-weeks after the last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months

Timeline

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

  1. First posted14 Oct 2019
  2. Study start11 May 2020
  3. Primary completion29 Jul 2025
  4. Study completion30 Oct 2026 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04126070
Sponsor's protocol ID
19-384
Status last verified
Jan 2026
First submitted
11 Oct 2019
Last updated
12 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Androgen Deprivation Therapy, Nivolumab and Docetaxel in people with Hormone Sensitive Prostate Cancer and Prostate Adenocarcinoma, run by Xiao X. Wei, MD at 6 sites 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 46 inclusion and 33 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 12 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 6 sites 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?

Yes. Results are posted in the registry (first posted 27 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Subjects With Prostate Specific Antigen (PSA) Less Than or Equal to 0.2 ng/mL at 7 Months From Start of Chemoimmunotherapy (time frame: 7 months from the start of chemoimmunotherapy). 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 NCT04126070.

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 12 Aug 2026.

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