Prostate Cancer Patients Treated by RadiotherapyPhase 2NCT07332000
A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
A Phase 2 study testing aglatimagene besadenovec + valacyclovir and External Beam Radiation Therapy (EBRT) in people with Prostate Cancer Patients Treated by Radiotherapy and Prostate Cancer (Adenocarcinoma), run by Candel Therapeutics, Inc. at 7 sites in United States.
Trial summary
Phase 2a, open-label, multi-center study evaluating biomarkers and biodistribution of aglatimagene besadenovec plus valacyclovir in men with localized, intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Patients Treated by Radiotherapy, Prostate Cancer (Adenocarcinoma)
- What is being tested?
- aglatimagene besadenovec + valacyclovir and External Beam Radiation Therapy (EBRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Oct 2025to Feb 2027
- 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
- Participants must give study-specific informed consent prior to enrollment
- Histologically confirmed adenocarcinoma of the prostate
- Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-risk criteria
- Participants must be planning and medically able to undergo standard or moderate hypofractionated prostate-only EBRT (treatment and control group) and able to tolerate multiple transrectal ultrasound guided injections (treatment group only)
- 18 years of age or older
- Performance status must be Eastern Cooperative Oncology Group 0-2
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- The following laboratory criteria must be met (treatment group only):
- Aspartate aminotransferase (AST) < 3 x upper limit of normal
- Serum creatinine < 2 mg/dL
- Calculated creatinine clearance > 30 mL/min
- White blood cells > 3000/mm3
- Platelets >100,000/mm3
Who cannot join
- Active liver disease, including known cirrhosis or active hepatitis
- Participants on systemic corticosteroids (> 10 mg prednisone per day) or other immunosuppressive drugs
- Known HIV+ participants
- Regional lymph node involvement or distant metastases
- Participants planning to receive whole pelvic irradiation
- Other current malignancy (except squamous or basal cell skin cancers)
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- Other serious co-morbid illness or compromised organ function that, in the opinion of the Investigator, would interfere with treatment or follow-up. For example, participants with diseases that preclude radiation therapy to the prostate such as severe prostatitis and inflammatory bowel disease.
- Prior treatment for prostate cancer except transurethral resection of the prostate (TURP). If prior TURP, participants must be deemed able to receive multiple intra-prostatic injections by the Investigator.
- Participants who had or plan to have orchiectomy as the form of hormonal ablation
- Known sensitivity or allergic reactions to acyclovir or valacyclovir (treatment group only)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Colorado Clinical Research
Lakewood, Colorado, 80228
Stephanie Melgar-Donis, 720-213-3130, Stephanie.melgar-donis@coloradouro.com
Thomas Facelle, M.D.
- Recruiting
Sheldon Freedman, MD Ltd.
Las Vegas, Nevada, 89144
Danielle Freedman, 702-732-0282 ext. 232, dfreedman@freedmanurology.com
Sheldon Freedman, M.D.
- Recruiting
Urology Associates
Littleton, Colorado, 80122
Kim Ulibarri, 303-733-8848 ext. 1615, kimberly.ulibarri@uradenver.com
James Fagelson, M.D.
- Recruiting
START Carolinas
Myrtle Beach, South Carolina, 29572
Matthew Parton, (843) 839-1679, matthew.parton@startresearch.com
Taylor Stephenson, (843) 839-1679, taylor.stephenson@startresearch.com
- Recruiting
Academic Urology and Urogynecology of Arizona
Peoria, Arizona, 85381
Jennifer Hill, 480-264-9958, jhill@academic-urology.com
Chandan Kundavaram, M.D.
- Recruiting
Summit Health
Saddle Brook, New Jersey, 07663
Michelle Mackenzie, RN OCN CCRC, 973-436-1755, Mmackenzie@summithealth.com
Glen Gejerman, M.D.
- Recruiting
Chesapeake Urology Research Associates
Towson, Maryland, 21204
Tenia Heigh, 443-471-5750, theigh@chesuro.com
Rayna B. Campbell, rbennett@chesuro.com
About this study
Official title: A Biomarker Study in Men With Localized, Favorable, Intermediate-risk Prostate Cancer Treated With Aglatimagene Besadenovec
Phase 2a, open-label, multi-center study evaluating biomarkers and biodistribution of aglatimagene besadenovec plus valacyclovir in men with localized, intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT).
Read the detailed description
This is a phase 2a, open-label, multi-center study evaluating aglatimagene besadenovec plus prodrug in men with localized, intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT). Aglatimagene besadenovec is a replication-deficient adenoviral vector encoding the herpes simplex virus thymidine kinase (HSV-tk) gene. When combined with an oral antiviral prodrug (valacyclovir), this approach induces targeted tumor cell death and stimulates a systemic immune response. The study aims to characterize:
- Viral shedding and biodistribution of CAN-2409 genomes in blood, urine, and semen using validated qPCR assays.
- Immune activation biomarkers, including lymphocyte subsets, cytokine profiles, and circulating tumor-related proteins.
Approximately 30 patients with intermediate risk prostate cancer will be recruited to the treatment arm and receive 3 courses of aglatimigene besadenovec by intraprostatic injection followed by orally administered valacyclovir. EBRT will start following the second injection. Biospecimens (blood, urine, semen) will be collected at specifed timepoints before and after each injection to assess biodistribution and immune response.
Approzimately 15 patients with intermediate risk prostate cancer will be recruited to the control arm receiving EBRT alone. Biospecimens (blood, urine, semen) will be collected at specified timepoints to assess immune response.
Safety will be monitored continuously. Frequency of treatment-emergent adverse events (TEAEs) and laboratory values will be evaluated for patients in the treatment arm. Patients in the control arm will be monitored for treatment-emergent serious adverse events suspected to be related to the collection of biospecimens.
- Being tested
- aglatimagene besadenovec + valacyclovir, External Beam Radiation Therapy (EBRT)
- Keywords
- Biomarkers, Viral Shedding, Prostate Cancer, Aglatimagene Besadenovec
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aglatimagene besadenovec + valacyclovirBiological
Also called CAN-2409 plus prodrug
aglatimagene besadenovec: a genetically modified replication-defective adenoviral vector expressing the herpes simplex virus (HSV) thymidine kinase (tk) gene. Patients in the treatment arm will receive 3 intraprostatic injections of aglatimagene besadenovec, with each injection followed by a 14-day course of valacyclovir. Patients will have aglatimagene besadenovec administered either transrectally or transperineally.
External Beam Radiation Therapy (EBRT)Radiation
Standard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients receiving aglatimagene besadenovec + valacyclovir along with External Beam Radiation Therapy (EBRT) Receives: Biological: aglatimagene besadenovec + valacyclovir; Radiation: External Beam Radiation Therapy (EBRT) |
| Control | Active comparator | External Beam Radiation Therapy (EBRT) alone Receives: Radiation: External Beam Radiation Therapy (EBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodistribution of aglatimagene besadenovec
Evaluation of shedding of aglatimagene besadenovec viral genomes in urine, blood, and semen samples using validated bioassays over time.
Measured: Up to 5 months post last injection of aglatimagene besadenovec.
Secondary outcomes (4)
Biomarkers of immune activation and tumor burden
Evaluation of prostate-specific antigen (PSA) ng/mL changes over time.
Measured: Up to 5 months post last injection of aglatimagene besadenovec.
Biomarkers of immune activation and tumor burden
Evaluation of changes in lymphocytes as a proportion of total immune cells over time (lymphocytes/PBMCs).
Measured: Up to 5 months post last injection of aglatimagene besadenovec.
Biomarkers of immune activation and tumor burden
Changes from baseline in concentrations of circulating proteins (e.g. Olink Normalized Protein Expression, or NPX).
Measured: Up to 5 months post last injection of aglatimagene besadenovec.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Measured: Up to 5 months post last injection of aglatimagene besadenovec.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start30 Oct 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Patients Treated by RadiotherapyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial contains an active treatment arm and control arm
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Candel Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332000
- Sponsor's protocol ID
- PrTK05
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biomarker Study in Men With Localized, Favorable, Intermediate-risk Prostate Cancer Treated With Aglatimagene Besadenovec
- ClinicalTrials.gov ID
- NCT07332000
- Acronym / sponsor ID
- PrTK05
- Keywords
- Biomarkers, Viral Shedding, Prostate Cancer, Aglatimagene Besadenovec
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Candel Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 12 Jan 2026 (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.
Phase 2a, open-label, multi-center study evaluating biomarkers and biodistribution of aglatimagene besadenovec plus valacyclovir in men with localized, intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT).
Detailed description
This is a phase 2a, open-label, multi-center study evaluating aglatimagene besadenovec plus prodrug in men with localized, intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT). Aglatimagene besadenovec is a replication-deficient adenoviral vector encoding the herpes simplex virus thymidine kinase (HSV-tk) gene. When combined with an oral antiviral prodrug (valacyclovir), this approach induces targeted tumor cell death and stimulates a systemic immune response. The study aims to characterize:
- Viral shedding and biodistribution of CAN-2409 genomes in blood, urine, and semen using validated qPCR assays.
- Immune activation biomarkers, including lymphocyte subsets, cytokine profiles, and circulating tumor-related proteins.
Approximately 30 patients with intermediate risk prostate cancer will be recruited to the treatment arm and receive 3 courses of aglatimigene besadenovec by intraprostatic injection followed by orally administered valacyclovir. EBRT will start following the second injection. Biospecimens (blood, urine, semen) will be collected at specifed timepoints before and after each injection to assess biodistribution and immune response.
Approzimately 15 patients with intermediate risk prostate cancer will be recruited to the control arm receiving EBRT alone. Biospecimens (blood, urine, semen) will be collected at specified timepoints to assess immune response.
Safety will be monitored continuously. Frequency of treatment-emergent adverse events (TEAEs) and laboratory values will be evaluated for patients in the treatment arm. Patients in the control arm will be monitored for treatment-emergent serious adverse events suspected to be related to the collection of biospecimens.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical trial contains an active treatment arm and control arm
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: aglatimagene besadenovec + valacyclovir, Radiation: External Beam Radiation Therapy (EBRT)Patients receiving aglatimagene besadenovec + valacyclovir along with External Beam Radiation Therapy (EBRT) |
| Control | Active comparator | Radiation: External Beam Radiation Therapy (EBRT)External Beam Radiation Therapy (EBRT) alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants must give study-specific informed consent prior to enrollment
- Histologically confirmed adenocarcinoma of the prostate
- Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-risk criteria
- Participants must be planning and medically able to undergo standard or moderate hypofractionated prostate-only EBRT (treatment and control group) and able to tolerate multiple transrectal ultrasound guided injections (treatment group only)
- 18 years of age or older
Key exclusion criteria (10 listed)
- Active liver disease, including known cirrhosis or active hepatitis
- Participants on systemic corticosteroids (> 10 mg prednisone per day) or other immunosuppressive drugs
- Known HIV+ participants
- Regional lymph node involvement or distant metastases
- Participants planning to receive whole pelvic irradiation
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 besadenovec + valacyclovirAlso: CAN-2409 plus prodrugaglatimagene besadenovec: a genetically modified replication-defective adenoviral vector expressing the herpes simplex virus (HSV) thymidine kinase (tk) gene. Patients in the treatment arm will receive 3 intraprostatic injections of aglatimagene besadenovec, with each injection followed by a 14-day course of valacyclovir. Patients will have aglatimagene besadenovec administered either transrectally or transperineally. | Biological | Treatment |
| External Beam Radiation Therapy (EBRT)Standard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT) | Radiation | Control, Treatment |
Primary outcome
Biodistribution of aglatimagene besadenovec
Time frame: Up to 5 months post last injection of aglatimagene besadenovec.
Evaluation of shedding of aglatimagene besadenovec viral genomes in urine, blood, and semen samples using validated bioassays over time.
4 secondary outcomes
Biomarkers of immune activation and tumor burden
Time frame: Up to 5 months post last injection of aglatimagene besadenovec.
Biomarkers of immune activation and tumor burden
Time frame: Up to 5 months post last injection of aglatimagene besadenovec.
Biomarkers of immune activation and tumor burden
Time frame: Up to 5 months post last injection of aglatimagene besadenovec.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Up to 5 months post last injection of aglatimagene besadenovec.
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 15 Sep 2026.
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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.
Academic Urology and Urogynecology of Arizona
Peoria, United States
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aglatimagene besadenovec + valacyclovir and External Beam Radiation Therapy (EBRT) in people with Prostate Cancer Patients Treated by Radiotherapy and Prostate Cancer (Adenocarcinoma), run by Candel Therapeutics, Inc. at 7 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 12 inclusion and 10 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of aglatimagene besadenovec (time frame: Up to 5 months post last injection of aglatimagene besadenovec.). 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 15 Sep 2026.