AzTrials
AzTrials

Prostate CancerPhase 2NCT02649855

Docetaxel and PROSTVAC for Metastatic Castration-Sensitive Prostate Cancer

A Phase 2 study testing PROSTVAC-V, PROSTVAC-F and Docetaxel in people with Prostate Cancer and Prostate Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: Metastatic castrate-sensitive prostate cancer is cancer that has spread beyond the prostate area. It can be controlled by lowering the amount of testosterone in the body. This is called androgen deprivation therapy (ADT). The vaccine PROSTVAC might help the immune system kill cancer cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
PROSTVAC-V, PROSTVAC-F and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteUnited States
Study dates
19 Jan 2016to 5 Dec 2023
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

  • Documented histopathological confirmation of prostate cancer-from a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
  • Patients must have metastatic disease, defined as at least one lesion on bone scan or at least one lesion that are measurable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (Patients who have metastatic disease by these criteria prior to ADT, but then have changes after androgen deprivation therapy (ADT) that diminish the size of these lesions or changes on bone scan are still eligible.)
  • Patients must have a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) criteria
  • Patients must have adequate bone marrow, hepatic, and renal function with:
  • Absolute neutrophil count (ANC) greater than or equal to 1500/microL, without cerebrospinal fluid (CSF) support
  • Platelets greater than or equal to 100,000/microL
Show all 20Show fewer
  • Aspartate aminotransferase (AST)/Serum glutamic-oxaloacetic transaminase (SGOT) less than or equal to 2.5 times upper limit of normal (ULN);
  • Alanine aminotransferase (ALT)/Serum glutamic-pyruvic transaminase (SGPT) less than or equal to 2.5 times upper limit of normal (ULN);
  • Total serum bilirubin less than or equal to 1.5 times upper limit of normal (ULN), OR in patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0)
  • Serum albumin greater than or equal to 2.8 g/dL
  • Lipase < 2.0 times the upper limit of normal and no radiologic or clinical evidence of pancreatitis
  • Creatinine less than or equal to 1.5 times institutional upper limits of normal
  • OR
  • Creatinine clearance of greater than or equal to 50 ml/min/1.73 m(2) for patients with creatinine levels above institutional normal by 24-hour urine.
  • Willing to travel to the National Institutes of Health (NIH) for follow-up visits
  • 18 years of age or older.
  • Able to understand and sign informed consent.
  • May have had up to 24 months of ADT (testosterone suppression therapy in the nonmetastatic setting) and are at least 12 months removed from treatment
  • Men treated or enrolled on this protocol must also agree to use adequate contraception, prior to the study, for the duration of study participation, and 4 months after completion. Sexually active subjects and their female partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must also agree to use both a barrier method and a second method of birth control during the course on the study and for 4 months after the last dose of study drug(s). Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
  • Must have started ADT for metastatic disease within 134 days (for Arm A and B) or within 28 days (for Arm C).

Who cannot join

  • Immunocompromised status due to:
  • Human immunodeficiency virus (HIV) positivity.
  • Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed.
  • Other immunodeficiency diseases
  • Chronic administration (defined as daily or every other day for continued use > 14 days) of corticosteroids deemed systemic by investigator within 28 days before the first planned dose of PROSTVAC. Use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed.
  • Evidence of rising prostate-specific antigen (PSA) on ADT
Show all 21Show fewer
  • Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient's ability to carry out the treatment program.
  • Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to poxviral vaccines (e.g., vaccinia vaccine)
  • Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin).
  • History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
  • Previous serious adverse reactions to smallpox vaccination
  • Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the Day 1 vaccination: (a) children less than or equal to 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with human immunodeficiency virus (HIV).
  • Receipt of an investigational agent within 28 days (or 60 days for an antibody-based therapy) before the first planned dose of study drugs.
  • Patients who test positive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Uncontrolled hypertension (systolic blood pressure (SBP)>170/ diastolic blood pressure (DBP)>105)
  • Patients who have had prior chemotherapy for prostate cancer.
  • The subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder).
  • The subject has active brain metastases or epidural disease.
  • Patients with greater than or equal to grade 2 peripheral neuropathy at baseline.
  • Patients with history of splenectomy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Docetaxel and Prostvac for Metastatic Castration Sensitive Prostate Cancer

Background:

Metastatic castrate-sensitive prostate cancer is cancer that has spread beyond the prostate area. It can be controlled by lowering the amount of testosterone in the body. This is called androgen deprivation therapy (ADT). The vaccine PROSTVAC might help the immune system kill cancer cells. Researchers want to add PROSTVAC and docetaxel chemotherapy to ADT. They think this may work better against prostate cancer than ADT alone.

Read more

Objective:

To test if adding PROSTVAC and docetaxel to ADT works better against prostate cancer than ADT alone.

Eligibility:

Men ages 18 years and over with metastatic castrate-sensitive prostate cancer

Design:

Participants will be screened with:

Physical exam

Medical history

Blood tests

Possible computed tomography (CT), magnetic resonance imaging (MRI), or bone scan: Participants lie in a machine. The machine takes pictures of the body.

Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.

Participants will have 2 optional tumor biopsies during the study.

Participants will join 1 of 2 groups. Both groups will get:

ADT

Docetaxel by vein

Steroids by mouth or vein before each docetaxel infusion

PROSTVAC injection

Both groups first have ADT. One to 4 months after, they have:

Group A:

Docetaxel every 3 weeks for 6 cycles

PROSTVAC 3 weeks after the last infusion

Booster injections 2 weeks later and then every 3 weeks, for 6 boosters total

Group B:

PROSTVAC

Booster 2 weeks later

Docetaxel hours later

Docetaxel and the booster every 3 weeks for 6 cycles

Participants will have a visit 4-5 weeks after the last treatment. They will then have visits every 12 weeks.

Participants will be followed for up to 15 years. This includes physical exams every year for 5 years.

Read the detailed description

Background:

  • A phase III trial demonstrated that combining docetaxel and androgen deprivation therapy (ADT) significantly improved survival (57.6 vs 44.0 months (hazard ration (HR)=0.56, (0.44-0.70), p <0.0001) for men with metastatic castration sensitive prostate cancer (mCSPC).
  • PROSTVAC (developed by the National Cancer Institute [NCI] and licensed to Bavarian Nordic Immunotherapeutics, Mountain View, California (CA) is a therapeutic cancer vaccine for prostate cancer.
  • Preclinical and clinical studies support the potential synergy in the combination of docetaxel and PROSTVAC. The potential to combine docetaxel with vaccine in mCSPC could improve upon the survival advantage that has been previously seen.

Objectives:

Primary

-To determine if PROSTVAC combined with docetaxel is able to induce greater antigen spreading (i.e. a broader immune response) with greater associated response score compared to docetaxel alone after 19 weeks.

Key Eligibility Criteria:

  • Must have castrate sensitive prostate cancer (rising PSA and testosterone over 100) or is within 134 days of starting ADT (Arm A or B) or within 28 days of start ADT (Arm C)
  • Histopathological confirmation of prostate cancer
  • Patients must have metastatic disease
  • Patients must have a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) criteria
  • Patients must have adequate bone marrow, hepatic, and renal function

Design

  • This is a randomized trial of ADT followed by simultaneous docetaxel 75 mg/m(2) every (q)3 weeks x 6 cycles + PROSTVAC q3 weeks x 6 cycles versus ADT followed by sequential docetaxel 75 mg/m(2) q3 weeks x 6 cycles followed by PROSTVAC q3 weeks x 6 cycles in men with newly diagnosed mCSPC.
  • Patients who have not started ADT or who have been on ADT 28 days or fewer will be assigned to treatment with PROSTVAC for 4 - 6 injections followed by docetaxel 75 mg/m^2 q3 weeks x 6 cycles.
Being tested
PROSTVAC-V, PROSTVAC-F, Docetaxel
Keywords
PSA, Vaccine, Immunotherapy, Immune Response, Androgen Deprivation Therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • PROSTVAC-VBiological

    It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.

  • PROSTVAC-FBiological

    It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.

  • DocetaxelDrug

    Also called Taxotere

    It is commercially available. It will be administered at 75 mg/m(2) intravenously.

Study groups in NCT02649855
Study groupRoleWhat they receive
Arm A/Sequential Docetaxel followed by PROSTVACExperimentalStandard androgen deprivation therapy (ADT) followed by sequential docetaxel + prostvac
Receives: Biological: PROSTVAC-V; Biological: PROSTVAC-F; Drug: Docetaxel
Arm B/ Combined Docetaxel with PROSTVACExperimentalStandard androgen deprivation therapy (ADT) followed by combined docetaxel + prostvac
Receives: Biological: PROSTVAC-V; Biological: PROSTVAC-F; Drug: Docetaxel
Arm C/ PROSTVAC Prior to DocetaxelExperimentalStandard androgen deprivation therapy (ADT) followed by prostvac, then docetaxel. No ADT for less than 28 days, prostvac prior to docetaxel.
Receives: Biological: PROSTVAC-V; Biological: PROSTVAC-F; Drug: Docetaxel

What is being measured

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

  1. Antigen Spreading (i.e., a Broader Immune Response) With Greater Associated Response Score Compared to Docetaxel Alone After 19 Weeks

    Antigen spreading as measured by antigen spread score. The antigen spreading score denotes the presence of a T-cell (cluster of differentiation(CD8)+ and/or cluster of differentiation 4(CD4+) immune response against 2 tumor associated antigens that were not targeted by PROSTVAC:Mucin 1(MUC-1) \& carcinoembryonic antigen(CEA). Antigen-specific T-cell responses were determined using intracellular cytokine staining of 4 established markers (Lysosome-associated membrane proteins h-LAMP1, interferon gamma, interleukin-2\& tumor necrosis factor) in both CD4+\& CD8+T-cells, giving a total of 8 measures of activation per antigen. Numbers of activation markers per antigen were totaled \& multiplied by 1.5 to give higher weighting to T-cell responses to antigens that were not targeted by PROSTVAC;\& the scores for both MUC-1 \& CEA were totaled per participant, with a possible range of 0-24 (0 is a negative result whereas 1.5-24 are positive results). The higher level of response, the better outcome.

    Measured: After 19 Weeks

Secondary outcomes (2)

  1. Antigen Specific T-cell Immune Composite Response Scores Between All Arms at 39 Weeks and 1 Year

    Response score denotes the presence of a T-cell (cluster of differentiation 8(CD8+) and/or cluster of differentiation 4(CD4+) response against 3 tumor associated antigens: prostate-specific antigen(PSA), mucin 1(MUC-1) and carcinoembryonic antigen(CEA). Antigen-specific T-cell immune responses were determined using intracellular cytokine staining of 4 established markers (Lysosome-associated membrane proteins h-LAMP1, interferon gamma, interleukin-2\& tumor necrosis factor in both CD4+ \& CD8+T-cells, a total of 8 measures of activation per antigen. The number of activation markers for PSA were totaled for a maximum score of 8. Numbers of activation markers for MUC-1 \& CEA were totaled \& multiplied by 1.5 to give higher weighting to T-cell responses to antigens that were not targeted by PROSTVAC. The scores for PSA, MUC-1 \& CEA were totaled per participant, with a possible range of 0-32 (0 is a negative result whereas 1-32 are positive results). Higher level of response, better outcome.

    Measured: 39 weeks and 1 year

  2. Number of Participants With T-cell Response to Prostate-specific Antigen (PSA)

    PSA-specific immune responses T-cell responses were assessed using nonparametric methods. The value denotes the number of participants with T-cell immune responses towards PSA. The higher level of response, the better outcome.

    Measured: 39 weeks and 1 year

Timeline

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

  1. First posted8 Jan 2016 (estimated)
  2. Study start19 Jan 2016
  3. Primary completion1 Jul 2022
  4. Study completion5 Dec 2023

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02649855
Sponsor's protocol ID
160048
Other IDs
16-C-0048
Status last verified
Apr 2026
First submitted
7 Jan 2016
Last updated
29 Apr 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PROSTVAC-V, PROSTVAC-F and Docetaxel in people with Prostate Cancer and Prostate Neoplasms, run by National Cancer Institute (NCI) 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 20 inclusion and 21 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: finished, as of the sponsor's last update on 29 Apr 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?

Yes. Results are posted in the registry (first posted 21 Jul 2023). 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?

Antigen Spreading (i.e., a Broader Immune Response) With Greater Associated Response Score Compared to Docetaxel Alone After 19 Weeks (time frame: After 19 Weeks). 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 NCT02649855.

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 29 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in