Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
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| ClinicalTrials.gov Identifier: NCT02768363 |
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Recruitment Status :
Active, not recruiting
First Posted : May 11, 2016
Last Update Posted : May 10, 2023
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Sponsor:
Candel Therapeutics, Inc.
Information provided by (Responsible Party):
Candel Therapeutics, Inc.
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Brief 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. 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Biological: aglatimagene besadenovec Biological: placebo Drug: valacyclovir | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 187 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer |
| Study Start Date : | May 2016 |
| Estimated Primary Completion Date : | December 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: CAN-2409
Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir
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Biological: aglatimagene besadenovec
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.
Other Names:
Drug: valacyclovir Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection. |
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Placebo Comparator: Placebo
Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
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Biological: placebo
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. Drug: valacyclovir Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection. |
Primary Outcome Measures :
- Progression-free survival [ Time Frame: Once all subjects have completed at least 3 years following randomization ]
Secondary Outcome Measures :
- Biochemical response (change in PSA) [ Time Frame: Assessed at each visit at 3, 6, 9 and 12 months then at least yearly ]
- Patient reported Health Related Quality of Life [ Time Frame: Assessed at each visit at 3, 6, 9 and 12 months ]
- Time to radical treatment [ Time Frame: 5 years ]
- The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase. [ Time Frame: Assessed at each visit at 3, 6, 9 and 12 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria include:
- Histologically confirmed adenocarcinoma of the prostate
- Patients choosing active surveillance
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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
- 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
Exclusion Criteria include:
- 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
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768363
Locations
Show 23 study locations
Sponsors and Collaborators
Candel Therapeutics, Inc.
| Responsible Party: | Candel Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT02768363 |
| Other Study ID Numbers: |
PrTK04 |
| First Posted: | May 11, 2016 Key Record Dates |
| Last Update Posted: | May 10, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Candel Therapeutics, Inc.:
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Immunotherapy Tumor vaccine Immuno-oncology |
Cytotoxicity Prostate cancer Active Surveillance |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases |
Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Valacyclovir Antiviral Agents Anti-Infective Agents |