Research & Clinical Trials

As a Texas Urology Specialists patient, you may have the opportunity to receive newly-developed treatments or investigational drugs through participation in clinical trials. Although they are unproven, new treatments and drugs may result in the alleviation of your symptoms.

To receive these experimental treatments, you will likely be required to participate in research studies or clinical trials. These clinical trials are designed to evaluate new treatment options as part of a deliberate and comprehensive research process that often takes years. Clinical trials test the safety and effectiveness of new or modified treatments in patients using new drugs, unique approaches to surgery and radiation therapy, or various combinations of treatments.

If you are interested in learning more about Research and Clinical Trials and if you qualify, please review the list of available trials below and discuss those options with your Texas Oncology Physician.

PrTK03 Combination w. Radiation

The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.

Eligibility:

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria include:

  • Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature
    • NCCN Intermediate Risk is defined as having at least one of the following: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
    • High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a
    • Excluded are those in the following risk groups: Low risk; High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
  • Planning to undergo standard prostate-only external beam radiation therapy
  • ECOG Performance Status 0-2

Exclusion Criteria include:

  • Liver disease, including known cirrhosis or active hepatitis
  • Patients on systemic corticosteroids (>10mg prednisone per day) or other immunosuppressive drugs
  • Known HIV+ patients
  • Regional lymph node involvement or distant metastases
  • Patients planning to receive whole pelvic irradiation
  • Prior treatment for prostate cancer, except TURP or ADT. For ADT, it may only be given for a maximum of 6 months
  • Patients who had or plan to have orchiectomy as the form of hormonal ablation
  • Known sensitivity or allergic reactions to acyclovir or valacyclovir

Further study details as provided by Advantagene, Inc.:

Primary Outcome Measures:

  • Disease free survival defined as the time from randomization until the date of the first failure event will be compared for the ProstAtak® arm versus the placebo control arm. The analyses will be based on the intent to treat population. [ Time Frame: Assessed at each visit every 6 months through year 5 until event occurs. ]

Secondary Outcome Measures:

  • Prostate cancer specific survival and overall survival will be compared for the ProstAtak® arm versus the placebo control arm. [ Time Frame: Assessed at each visit every 6 months through year 5 after which long-term follow up of general health status will continue yearly. ]
  • PSA nadir will be compared for the ProstAtak® arm versus the placebo control arm. [ Time Frame: Assessed at each visit every 6 months through year 5. ]
  • Patient reported Health Related Quality of Life outcomes will be collected using the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. The change in QOL over time will be compared for the ProstAtak® arm versus the placebo control arm. [ Time Frame: Assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation. ]
  • The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase (until the completion of radiation). Data on late effects will be collected after radiation completion. [ Time Frame: Assessed at each visit and continuously throughout the study. ]

Estimated Enrollment: 711
Study Start Date: September 2011
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Interested patients can schedule a consultation with Dr. Steven Sukin at 281-351-5174.

PrTK04 Ulysses Active Surveillance

The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in patients undergoing active surveillance for localized prostate cancer. ProstAtak® involves the use of aglatimagene besadenovec (AdV-tk) to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak® has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak® or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.

Eligibility:

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria include:

  • Histologically confirmed adenocarcinoma of the prostate
  • Patients choosing active surveillance
  • Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature
    • NCCN Low Risk is defined as having all of the following: PSA < 10 ng/ml, Gleason ≤ 6, T1-T2a
    • NCCN Intermediate Risk is defined as having at least one of the following and no high risk features: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
    • High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a
    • Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
  • Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections.
  • ECOG Performance status 0-2

Exclusion Criteria include:

  • Active liver disease, including known cirrhosis or active hepatitis
  • Patients on systemic corticosteroids (>10 mg prednisone per day) or other immunosuppressive drugs
  • Known HIV+ patients
  • Regional lymph node involvement or distant metastases
  • Other current malignancy (except squamous or basal cell skin cancers)
  • Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up
  • Prior treatment for prostate cancer except TURP. If prior TURP, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator
  • Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)
  • Patients who had or plan to use ADT or have history of an orchiectomy.
  • Patients who are planning to undergo radical treatment for prostate cancer within 12 months.
  • Known sensitivity or allergic reactions to acyclovir or valacyclovir

Further study details as provided by Advantagene, Inc.:

Primary Outcome Measures:

  • Proactive surveillance score [ Time Frame: 12 months ]

Secondary Outcome Measures:

  • Biochemical response (change in PSA) [ Time Frame: Assessed at each visit at 3, 6, 9 and 12 months ]
  • Patient reported Health Related Quality of Life [ Time Frame: Assessed at each visit at 3, 6, 9 and 12 months ]
  • Time to radical treatment [ Time Frame: 5 years ]
  • The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase. [ Time Frame: Assessed at each visit at 3, 6, 9 and 12 months ]

Estimated Enrollment: 156
Study Start Date: May 2016
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Interested patients can schedule a consultation with Dr. Steven Sukin at 281-351-5174.

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Michael White