Prostate CancerPhase 2NCT02768363
Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
A Phase 2 study testing aglatimagene besadenovec and valacyclovir in people with Prostate Cancer, run by Candel Therapeutics, Inc. at 23 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer. CAN-2409 involves the use of aglatimagene besadenovec to kill tumor cells and stimulate a cancer vaccine effect. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- aglatimagene besadenovec and valacyclovir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 23 sitesin 2 countries
- Study dates
- May 2016to Dec 2026
- 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
- Histologically confirmed adenocarcinoma of the prostate
- Patients choosing active surveillance
- Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature
- NCCN Low Risk is defined as having all of the following: PSA < 10 ng/ml, Gleason ≤ 6, T1-T2a
- NCCN Intermediate Risk is defined as having at least one of the following and no high risk features: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
- High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a
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- Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
- Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections.
- ECOG Performance status 0-2
Who cannot join
- Active liver disease, including known cirrhosis or active hepatitis
- Patients on systemic corticosteroids (>10 mg prednisone per day) or other immunosuppressive drugs
- Known HIV+ patients
- Regional lymph node involvement or distant metastases
- Other current malignancy (except squamous or basal cell skin cancers)
- Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up
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- Prior treatment for prostate cancer except TURP. If prior TURP, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator
- Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)
- Patients who had or plan to use ADT or have history of an orchiectomy.
- Patients who are planning to undergo radical treatment for prostate cancer within 12 months.
- Known sensitivity or allergic reactions to acyclovir or valacyclovir
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States22 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Ralph H. Johnson Veterans Affairs Medical Center
Charleston, South Carolina, 29401
Jesse Brown VA Medical Center
Chicago, Illinois, 60612
The University of Chicago
Chicago, Illinois, 60637
Foothills Urology
Golden, Colorado, 80401
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Lancaster Urology
Lancaster, Pennsylvania, 17604
Southwest Urology, Clinical Research Solutions
Middleburg Heights, Ohio, 44130
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, 70119
Advanced Radiation Centers of New York (Integrated Medical Professionals)
North Hills, New York, 11042
Oklahoma City VA Healthcare System
Oklahoma City, Oklahoma, 73104
Allegheny Health Network-Triangle Urological Group
Pittsburgh, Pennsylvania, 15212
VA Portland Health Care System
Portland, Oregon, 97239
Sierra Nevada Health Care System VA
Reno, Nevada, 89502
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Salem VA Medical Center
Salem, Virginia, 24153
San Antonio VA Healthcare System
San Antonio, Texas, 78229-4404
Oregon Urology Insitute
Springfield, Oregon, 97477
Associated Medical Professionals of NY, PLLC
Syracuse, New York, 13210
Woodland Center
The Woodlands, Texas, 77384
Texas Urology Specialists
Tomball, Texas, 77375
Mexico1 site
Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán
Mexico City
About this study
Official title: A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer
The purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer. CAN-2409 involves the use of aglatimagene besadenovec to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. CAN-2409 has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that CAN-2409 can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the CAN-2409 or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.
- Conditions
- Prostate Cancer
- Being tested
- aglatimagene besadenovec, placebo, valacyclovir
- Keywords
- Immunotherapy, Tumor vaccine, Immuno-oncology, Cytotoxicity, Prostate cancer, Active Surveillance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aglatimagene besadenovecBiological
Also called AdV-tk, CAN-2409
Aglatimagene besadenovec will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second aglatimagene besadenovec injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.
placeboBiological
Placebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.
valacyclovirDrug
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.
| Study group | Role | What they receive |
|---|---|---|
| CAN-2409 | Active comparator | Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir Receives: Biological: aglatimagene besadenovec; Drug: valacyclovir |
| Placebo | Placebo comparator | Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir Receives: Biological: placebo; Drug: valacyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival is defined as the time from randomization to evidence of histological disease progression or death due to prostate cancer
Measured: Baseline to study completion, approximately 5 years
Secondary outcomes (2)
Negative biopsy rate at 1-year landmark
Measured: 1 year
Percentage of patients with adverse events
Measured: 30 days after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candel Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768363
- Sponsor's protocol ID
- PrTK04
- Status last verified
- Sep 2026
- First submitted
- 6 May 2016
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer
- ClinicalTrials.gov ID
- NCT02768363
- Acronym / sponsor ID
- PrTK04
- Conditions
- Prostate Cancer
- Keywords
- Immunotherapy, Tumor vaccine, Immuno-oncology, Cytotoxicity, Prostate cancer, Active Surveillance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Candel Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Nov 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 May 2016 (estimated)
- 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 purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer. CAN-2409 involves the use of aglatimagene besadenovec to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. CAN-2409 has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that CAN-2409 can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the CAN-2409 or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAN-2409 | Active comparator | Biological: aglatimagene besadenovec, Drug: valacyclovirPatients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir |
| Placebo | Placebo comparator | Biological: placebo, Drug: valacyclovirPatients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed adenocarcinoma of the prostate
- Patients choosing active surveillance
- Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature
- Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections.
- ECOG Performance status 0-2
Key exclusion criteria (11 listed)
- Active liver disease, including known cirrhosis or active hepatitis
- Patients on systemic corticosteroids (>10 mg prednisone per day) or other immunosuppressive drugs
- Known HIV+ patients
- Regional lymph node involvement or distant metastases
- Other current malignancy (except squamous or basal cell skin cancers)
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 |
|---|---|---|
| aglatimagene besadenovecAlso: AdV-tk, CAN-2409Aglatimagene besadenovec will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second aglatimagene besadenovec injection will be 2-3 weeks after the first followed by 14 days of valacyclovir. | Biological | CAN-2409 |
| placeboPlacebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir. | Biological | Placebo |
| valacyclovirOral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection. | Drug | CAN-2409, Placebo |
Primary outcome
Progression-free survival (PFS)
Time frame: Baseline to study completion, approximately 5 years
Progression-free survival is defined as the time from randomization to evidence of histological disease progression or death due to prostate cancer
2 secondary outcomes
Negative biopsy rate at 1-year landmark
Time frame: 1 year
Percentage of patients with adverse events
Time frame: 30 days after last dose of study drug
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 2 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aglatimagene besadenovec and valacyclovir in people with Prostate Cancer, run by Candel Therapeutics, Inc. at 23 sites in 2 countries.
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 9 inclusion and 11 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Mexico. 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. Some participants in this study may receive a placebo. 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?
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?
Progression-free survival (PFS) (time frame: Baseline to study completion, approximately 5 years). 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 2 Oct 2026.