NCT03541928 Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery
| NCT ID | NCT03541928 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The Methodist Hospital Research Institute |
| Condition | High-risk Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2018-08-02 |
| Primary Completion | 2023-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2018-08-02 with a primary completion date of 2023-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
E. Brian Butler, MD
PRINCIPAL INVESTIGATOR
The Methodist Hospital Research Institute
Frequently Asked Questions
Who can join the NCT03541928 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying High-risk Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03541928 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03541928 currently recruiting?
Yes, NCT03541928 is actively recruiting participants. Contact the research team at khsiao@houstonmethodist.org for enrollment information.
Where is the NCT03541928 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT03541928 clinical trial?
NCT03541928 is sponsored by The Methodist Hospital Research Institute. The principal investigator is E. Brian Butler, MD at The Methodist Hospital Research Institute. The trial plans to enroll 60 participants.
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