Basic Information




Gene symbol tk


GTO ID GTC0046
Trial ID NCT00583492
Disease Prostate Cancer
Altered gene E1|E3|yCD|tk|ADP
Therapeutic/Target gene Therapeutic gene
TherapyDNA oncolytic virus
Treatment AdV5-yCD/mutTKSR39rep-ADP
Co-treatment intensity modulated radiotherapy (IRMT)
PhasePhase2
Recruitment statusCompleted
TitleA Randomized, Controlled Trial of Replication-Competent Adenovirus-Mediated Suicide Gene Therapy in Combination With IMRT Versus IMRT Alone for the Treatment of Newly-Diagnosed Prostate Cancer With an Intermediate Risk Profile
Year2007
CountryUnited States
Company sponsorHenry Ford Health System
Other ID(s)Prostate4809
Vector information
Vectoradenovirus
ConstructAd5-yCD/mutTKSR39rep-ADP
Vector typesecond-generation adenovirus vector
Transgene/Inserted geneyCD; HSV-TK; ADP
Viral genome modificationAd5-yCD/mutTKSR39rep-ADP contains a yeast cytosine deaminase (yCD)/mutantSR39 herpes simplex virus thymidine kinase (mutTKSR39) fusion gene in the E1 region as well as the Ad5 adenoviral death protein (ADP) gene in the E3 region. Both the yCD/mutTKSR39 and ADP genes are under the transcriptional control of the human cytomegalovirus promoter and produce high constitutive levels of the yCD/mutTKSR39 fusion and ADP proteins.

Clinical Result

Cohort 1
Administration route injection
Dosage 1E12 vp
Pts 21
Age Adult, Older_Adult
Outcome 20 Participants Freedom From Biochemical/Clinical Failure (FFF).
Adverse reactions 21/21(Blood and lymphatic system disorders; Hepatobiliary disorders; Respiratory, thoracic and mediastinal disorders)

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