Clinical trial · Interventional
Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery
Phase II Study Evaluating HSV-tk + Valacyclovir Gene Therapy in Combination With Androgen Deprivation Therapy, Brachytherapy, External Beam Radiotherapy, and Prostatectomy for High-Risk Prostate Cancer
NCT03541928CI-TRIAL-00051092recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective phase II study to assess the efficacy and toxicity of HSV-tk+ valacyclovir gene therapy in combination with androgen deprivation therapy, brachytherapy, external beam radiotherapy, and prostatectomy in previously untreated high-risk prostate cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-risk Prostate Cancer | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide | ALIAS |
| Brachytherapy, External beam radiotherapy | Radiation | — | UNRESOLVED |
| HSV-Tk | Drug | — | UNRESOLVED |
| Leuprolide Acetate | Drug | Leuprolide | ALIAS |
| Radical prostatectomy | Procedure | — | UNRESOLVED |
| Valacyclovir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gene Therapy, ADT, RT, and Surgery
- description
- The investigational gene therapy, ADV/HSV-tk, will be administered by injection into the prostate at 5 x 10\[11\] virus particles (1.25 x 10\[11\] virus particles per tumor quadrant in 4 quadrants) on day 0 and day 30. The recommended dose of Valacyclovir for this trial is 2 g orally t.i.d. for 14 days (day 1 to day 15 and days 31 to 45). The recommended dose for Bicalutamide therapy in combination with an LHRH analogue is one 50 mg tablet once daily (morning or evening). Leuprolide acetate 7.5mg depot injection will be injected monthly for a total of 2 months.
- interventionNames
- Drug: HSV-Tk
- Drug: Valacyclovir
- Drug: Bicalutamide
- Drug: Leuprolide Acetate
- Radiation: Brachytherapy, External beam radiotherapy
- Procedure: Radical prostatectomy
Primary outcomes (1)
- measure
- Biochemical control rate
- timeFrame
- 5-year biochemical disease free survival rate
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients must have biopsy proven adenocarcinoma of the prostate * Patients in should have at least one or more of the following characteristics PSA\>20, Gleason score 8-10, Primary Gleason pattern 5, \>4 cores with Gleason 8-10, and Clinical stage T3a-T4. * No prior surgical, hormonal, or radiotherapy prostate treatment. * ECOG performance status 0-1 * No evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers. * Patients must have PSA within 3 months of entry. * Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks of the study by the investigator (or his/her designee) with the aid of written information. * Willing to provide biopsies as required by the study. * Patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol: * serum creatinine \< 1.5 mg% * T. bilirubin \< 2.5 mg%, ALT and AST \< 2x normal * Pts \> 100,000/mm3 , ANC\> 1500 mm , Hgb\> 10gm% * Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT) Exclusion Criteria: * Prior treatment with immunomodulatory therapy, immunotherapy, and/or gene vector therapy in the past 3 months. * Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug within 3 weeks of study treatment start. * Evidence of metastatic disease * Prostate volume \>50cc * Prior prostate surgery (hyperthermia, cryotherapy, etc.) * Prior pelvic radiotherapy * Prior androgen ablation hormonal therapy (except finasteride if discontinued \> 3 mo. prior to enrollment) * Patients on corticosteroids or any immunosuppressive drugs. * History of liver disease, such as cirrhosis or active/chronic hepatitis B or C. * History of or current alcohol misuse/abuse within the past 12 months. * Known or suspected allergy or hypersensitivity to any component of the proposed regimen (gene vector/Valacyclovir). * Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications (Valacyclovir). * No active malignancy except for non-melanoma skin cancer or in situ cervical cancer or treated cancer from which the patient has been continuously disease free for more than 5 years. * Presence of active or suspected acute or chronic uncontrolled infection or history of immunocompromise, including a positive HIV test result. * Patients \< 18 years of age * Unwilling or unable to comply with the study protocol.
References
Publications (12)
- BACKGROUNDFerlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516. PMID 21351269
- BACKGROUNDZagars GK, Pollack A, Kavadi VS, von Eschenbach AC. Prostate-specific antigen and radiation therapy for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 1995 May 15;32(2):293-306. doi: 10.1016/0360-3016(95)00077-C. PMID 7538498
- BACKGROUNDAl-Mamgani A, van Putten WL, van der Wielen GJ, Levendag PC, Incrocci L. Dose escalation and quality of life in patients with localized prostate cancer treated with radiotherapy: long-term results of the Dutch randomized dose-escalation trial (CKTO 96-10 trial). Int J Radiat Oncol Biol Phys. 2011 Mar 15;79(4):1004-12. doi: 10.1016/j.ijrobp.2009.12.039. Epub 2010 Apr 24. PMID 20421153
- BACKGROUNDTeh BS, Ayala G, Aguilar L, Mai WY, Timme TL, Vlachaki MT, Miles B, Kadmon D, Wheeler T, Caillouet J, Davis M, Carpenter LS, Lu HH, Chiu JK, Woo SY, Thompson T, Aguilar-Cordova E, Butler EB. Phase I-II trial evaluating combined intensity-modulated radiotherapy and in situ gene therapy with or without hormonal therapy in treatment of prostate cancer-interim report on PSA response and biopsy data. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1520-9. doi: 10.1016/j.ijrobp.2003.09.083. PMID 15050332
- BACKGROUNDTeh BS, Aguilar-Cordova E, Vlachaki MT, Aguilar L, Mai WY, Caillouet J, Davis M, Miles B, Kadmon D, Ayala G, Lu HH, Chiu JK, Carpenter LS, Woo SY, Grant WH 3rd, Wheeler T, Thompson TC, Butler EB. Combining radiotherapy with gene therapy (from the bench to the bedside): a novel treatment strategy for prostate cancer. Oncologist. 2002;7(5):458-66. doi: 10.1634/theoncologist.7-5-458. PMID 12401909
- BACKGROUNDYossepowitch O, Eggener SE, Bianco FJ Jr, Carver BS, Serio A, Scardino PT, Eastham JA. Radical prostatectomy for clinically localized, high risk prostate cancer: critical analysis of risk assessment methods. J Urol. 2007 Aug;178(2):493-9; discussion 499. doi: 10.1016/j.juro.2007.03.105. Epub 2007 Jun 11.