Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aglatimagene besadenovec + valacyclovir — BIOLOGICAL
  Patients will receive three courses of ProstAtak® each consisting of aglatimagene besadenovec injection + oral valacyclovir. AdV-tk injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows: 1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. 2. The second injection will be 0-3 days before initiation of radiation therapy. 3. The third injection will be 15-22 days after the 2nd injection. The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each AdV-tk injection. Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification.
• Placebo + valacyclovir — BIOLOGICAL
  Patients will receive three courses each consisting of placebo injection + oral valacyclovir. Placebo injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows: 1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. 2. The second injection will be 0-3 days before initiation of radiation therapy. 3. The third injection will be 15-22 days after the 2nd injection. The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each placebo injection. Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification.

Study Details

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.

Key Dates

Start date

Sep 30, 2011

Status verified

Jul 2025

Primary completion

Aug 31, 2024

Completion

Dec 31, 2030

Study Design

Enrollment

711 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ProstAtak®
  Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT
• Placebo Comparator: Control
  Placebo + valacyclovir + radiation therapy +/- ADT

Primary Outcome Measure

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. ]

Locations (72)

Find similar trials in Gilbert, AZ

Related Studies

• Collection of Blood From Patients With Cancer
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
  Enrolling By Invitation · National Institutes of Health Clinical Center (CC) · Bethesda, Maryland
• Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
  Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey