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Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer

Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer After Definitive Radiotherapy

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02555397
Enrollment
15
Registered
2015-09-21
Start date
2015-08-31
Completion date
2024-01-22
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Locally Recurrent, Gene Therapy, IL-12, Adenovirus

Brief summary

The primary purpose of this phase 1 study is to determine the dose-dependent toxicity and maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic and IL-12 gene therapy in men with locally recurrent prostate cancer after definitive radiotherapy

Interventions

BIOLOGICALAd5-yCD/mutTKSR39rep-hIL12

Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 on day 1

Sponsors

Henry Ford Health System
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Biopsy-proven local recurrence of prostate cancer at least one year after the completion of definitive radiation therapy * Evidence of biologically active disease as demonstrated by an unequivocally rising serum PSA level that is ≥ 2 ng/mL above the nadir * PSA \< 100 ng/mL * Age ≥ 18 years * Karnofsky performance status ≥ 70 * Negative lymph nodes as established by imaging (pelvic CT or pelvic MRI) * No evidence of metastatic disease, as evaluated by bone scan and CT scan of the abdomen and pelvis. * Subjects must have adequate baseline organ function as assessed by the the following laboratory values: * Adequate renal function with serum creatinine ≤ 1.5 mg/dL * Platelet count \> 100,000/µL * Absolute neutrophil count \> 1,000/µL * Hemoglobin \> 10.0 g/dL * Bilirubin \> 1.5 mg/dL * AST/SGOT and ALT/SGPT \< 3.0 times upper limit of normal (ULN) * Men of child-producing potential must be willing to consent to use effective contraception for at least 3 months after the gene therapy * Subjects must possess the ability to give informed consent and express a willingness to meet all of the expected requirements of the protocol for the duration of the study

Exclusion criteria

* PSA ≥ 100 ng/mL * Prostate volume \> 100 cc * Pathologically positive lymph nodes or nodes \> 1.0 cm on imaging (nodes \> 1.0 cm but biopsy negative are allowed. * Evidence of M1 metastatic disease * Prior invasive malignancy except for non-melanoma skin cancer within 5 years of enrollment. Subjects must be disease-free for \> 5 years * Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason * If the subject had prior androgen deprivation therapy (ADT), the subject exhibited biochemical failure while on ADT * Prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowed; however, subjects must be \> 2 years post-completion of chemotherapy at the time of registration. Subjects on Proscar therapy must stop to be eligible) * Major surgery planned within 3 months of registration * Severe, active co-morbidity defined as: * New York Health Association Class II or greater congestive heart failure or active ventricular arrhythmia requiring medication * Chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization within last 3 months or precluding study therapy at the time of registration * Acute infection * Previous history of liver disease including hepatitis * Immunosuppressive therapy including systemic corticosteroids (use of inhaled and topical corticosteroids is permitted) * Impaired immunity or susceptibility to serious viral infections * Allergy to any product used in the protocol. If the subject has an allergy to Ciproflaxin, another antibiotic can be substituted at the discretion of the treating physician * Serious medical or psychiatric illness or concomitant medication, which, in the judgement of the principal investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial

Design outcomes

Primary

MeasureTime frame
Dose-dependent Toxicity30 days from date of adenovirus injection (defined as day 1)

Secondary

MeasureTime frame
PSA Response2 years
Freedom From Biochemical/Clinical Failure (FFF)2 years
Disease-specific and Overall Survival5 years
Quality of Life (QOL)2 years
PSA Doubling Time (PSADT)2 years

Other

MeasureTime frame
Association Between the Primary and Secondary Outcomes and Immunological Endpoints Including Serum IL-12 and IFN-y Levels and NK Cell Cytolytic Activity3 months

Countries

United States

Participant flow

Recruitment details

Participants were recruited based on physician referral from the department of Radiation Oncology and the department of Urology at the Henry Ford Cancer Institute, Henry Ford Health System

Participants by arm

ArmCount
AdV Dose: 1X10e10 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 viral particles.
3
AdV Dose: 3x10e10 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 3 x 10e10 viral particles.
3
AdV Dose: 1x10e11 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1x10e11 viral particles.
3
AdV Dose: 3x10e11 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 3x10e11 viral particles.
3
AdV Dose: 1x10e12 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1x10e12 viral particles.
3
Total15

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Overall StudyWithdrawal by Subject10000

Baseline characteristics

CharacteristicAdV Dose: 1X10e10 vpTotalAdV Dose: 1x10e12 vpAdV Dose: 3x10e11 vpAdV Dose: 1x10e11 vpAdV Dose: 3x10e10 vp
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants15 Participants3 Participants3 Participants3 Participants3 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Gleason Score
10
1 participants1 participants0 participants0 participants0 participants0 participants
Gleason Score
6
0 participants1 participants1 participants0 participants0 participants0 participants
Gleason Score
7
0 participants4 participants1 participants0 participants1 participants2 participants
Gleason Score
8
2 participants4 participants0 participants0 participants2 participants0 participants
Gleason Score
9
0 participants3 participants0 participants2 participants0 participants1 participants
Gleason Score
Not assessed
0 participants2 participants1 participants1 participants0 participants0 participants
Pre-T PSA (ng/ml)
>=10 ng/mL
1 Participants5 Participants1 Participants1 Participants1 Participants1 Participants
Pre-T PSA (ng/ml)
>=4 and <10 ng/mL
0 Participants4 Participants2 Participants1 Participants1 Participants0 Participants
Pre-T PSA (ng/ml)
<4 ng/mL
2 Participants6 Participants0 Participants1 Participants1 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants9 Participants2 Participants3 Participants2 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
3 Participants5 Participants1 Participants0 Participants0 Participants1 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
3 Participants15 Participants3 Participants3 Participants3 Participants3 Participants
Tumor Stage
Not Detected
0 Participants1 Participants0 Participants1 Participants0 Participants0 Participants
Tumor Stage
T1c
3 Participants11 Participants3 Participants1 Participants2 Participants2 Participants
Tumor Stage
T2
0 Participants3 Participants0 Participants1 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 30 / 30 / 30 / 30 / 3
other
Total, other adverse events
3 / 32 / 32 / 33 / 33 / 3
serious
Total, serious adverse events
0 / 30 / 30 / 30 / 30 / 3

Outcome results

Primary

Dose-dependent Toxicity

Time frame: 30 days from date of adenovirus injection (defined as day 1)

Population: Arm specific adverse events

ArmMeasureGroupValue (NUMBER)
AdV Dose: 1X10e10 vpDose-dependent ToxicityAnemia1 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityALKP increased1 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityLeukopenia0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityHypomagnesemia0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityLymphopenia3 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityDehydration0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityNeutropenia0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityAST/SGOT increased0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityThrombocytopenia0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityALT/SGPT increased1 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityDiarrhea0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityDyspnea1 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityChills0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityHyperglycemia1 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityFatigue2 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityFever0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityFlu-like symptoms0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityCreatinine increased0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityHypercalcemia1 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityHypotension0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityHyponatremia1 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityNausea1 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityCytokine release syndrome0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityUrinary frequency1 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityUrinary incontinence0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityGGT increased0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityUrinary retention0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityUrinary tract pain0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityVomiting1 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityMental status change0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityCPK increased1 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityMalaise0 participants
AdV Dose: 1X10e10 vpDose-dependent ToxicityPain (thigh, kidney, head, fingers)0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityCytokine release syndrome0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityFlu-like symptoms1 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityAnemia0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityGGT increased0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityPain (thigh, kidney, head, fingers)0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityLeukopenia2 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityVomiting0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityUrinary incontinence0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityChills2 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityHypotension0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityLymphopenia1 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityUrinary tract pain0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityHypomagnesemia1 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityAST/SGOT increased0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityMental status change0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityNeutropenia0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityFever0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityDehydration0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityDyspnea0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityUrinary retention0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityThrombocytopenia0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityNausea0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityFatigue1 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityALKP increased0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityHypercalcemia0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityALT/SGPT increased1 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityMalaise0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityUrinary frequency1 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityCreatinine increased0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityDiarrhea1 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityCPK increased1 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityHyponatremia0 participants
AdV Dose: 3x10e10 vpDose-dependent ToxicityHyperglycemia0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityUrinary retention0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityDyspnea0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityUrinary tract pain0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityFatigue0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityHypercalcemia1 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityFever0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityChills0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityFlu-like symptoms0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityVomiting0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityHypotension0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityPain (thigh, kidney, head, fingers)0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityHypomagnesemia0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityMental status change0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityNausea0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityGGT increased0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityUrinary frequency0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityAnemia1 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityCreatinine increased0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityMalaise0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityLeukopenia2 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityAST/SGOT increased1 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityUrinary incontinence0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityLymphopenia2 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityCytokine release syndrome0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityNeutropenia1 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityALKP increased0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityThrombocytopenia1 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityDehydration0 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityALT/SGPT increased1 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityCPK increased2 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityHyponatremia1 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityHyperglycemia1 participants
AdV Dose: 1x10e11 vpDose-dependent ToxicityDiarrhea0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityGGT increased0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityCPK increased3 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityCreatinine increased0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityChills2 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityCytokine release syndrome0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityMental status change0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityDehydration0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityDiarrhea0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityDyspnea1 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityFatigue1 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityFever2 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityFlu-like symptoms1 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityHypotension0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityNausea1 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityUrinary frequency0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityUrinary incontinence0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityUrinary retention0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityUrinary tract pain0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityVomiting1 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityMalaise1 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityPain (thigh, kidney, head, fingers)1 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityAnemia0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityLeukopenia1 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityLymphopenia2 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityNeutropenia1 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityThrombocytopenia2 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityALT/SGPT increased1 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityAST/SGOT increased1 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityALKP increased0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityHypercalcemia1 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityHyperglycemia0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityHypomagnesemia0 participants
AdV Dose: 3x10e11 vpDose-dependent ToxicityHyponatremia1 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityAST/SGOT increased2 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityAnemia1 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityPain (thigh, kidney, head, fingers)3 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityMalaise3 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityChills3 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityALKP increased0 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityVomiting0 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityUrinary tract pain0 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityUrinary retention0 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityUrinary incontinence0 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityUrinary frequency1 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityNausea2 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityHypotension0 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityGGT increased0 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityFlu-like symptoms1 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityFever3 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityFatigue3 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityCreatinine increased1 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityHypercalcemia0 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityDyspnea0 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityDiarrhea3 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityDehydration2 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityCPK increased1 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityHyperglycemia2 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityMental status change1 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityCytokine release syndrome0 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityThrombocytopenia2 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityHyponatremia2 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityALT/SGPT increased1 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityNeutropenia1 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityLymphopenia3 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityLeukopenia3 participants
AdV Dose: 1x10e12 vpDose-dependent ToxicityHypomagnesemia0 participants
Secondary

Disease-specific and Overall Survival

Time frame: 5 years

Secondary

Freedom From Biochemical/Clinical Failure (FFF)

Time frame: 2 years

Secondary

PSA Doubling Time (PSADT)

Time frame: 2 years

Secondary

PSA Response

Time frame: 2 years

Secondary

Quality of Life (QOL)

Time frame: 2 years

Other Pre-specified

Association Between the Primary and Secondary Outcomes and Immunological Endpoints Including Serum IL-12 and IFN-y Levels and NK Cell Cytolytic Activity

Time frame: 3 months

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026