Clinical trial for High-risk Prostate Cancer
Official title Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery
ClinicalTrials.gov ID: NCT03541928
What this study is testing
What is HSV-Tk gene therapy?
An investigational gene therapy being studied as a potential treatment for high‑risk prostate cancer. It is designed to deliver the HSV‑tk gene into prostate cells so that, when a prodrug such as valacyclovir is given, the enzyme converts it into a toxic form that can kill the treated cells and nearby cancer cells through a by‑stander effect.
Also referred to as Gene therapy, AdV-tk gene therapy, Herpes simplex virus thymidine kinase.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to learn how effective and safe this gene therapy is when added to standard hormone therapy, radiation and surgery for high‑risk prostate cancer.
- Who it's for
- Men who have just been diagnosed with high‑risk prostate cancer and have not received any prior treatment.
- What's involved
- Participants will receive HSV‑tk gene therapy together with valacyclovir, androgen deprivation (hormone) therapy, brachytherapy, external‑beam radiation, and later a prostatectomy, along with regular medical visits and tests.
- Time commitment
- The trial runs for several months and requires multiple clinic visits for treatment administration and follow‑up assessments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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
See the full eligibility 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...
- Willing to provide biopsies as required by the study.
- 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)
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.