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NCT01436968 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer
A Phase 3 study of Prostate Cancer, sponsored by Candel Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 711
- Enrollment target
- 20
- Study locations
NCT01436968 is a Phase 3 study of Prostate Cancer that is active but no longer recruiting, run by Candel Therapeutics. The registered enrollment target is 711 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (17% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT01436968, a Phase 3 study of Prostate Cancer, is active but no longer recruiting, sponsored by Candel Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 711 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Aglatimagene besadenovec + valacyclovir
- BIOLOGICAL Placebo + valacyclovir
Study Locations (20)
Arizona
- Arizona Center for Cancer Care - Gilbert - Gilbert
- Arizona Urology Specialists - Glendale
- Arizona Oncology Services Foundation - Multiple Locations
- Arizona Center for Cancer Care - Peoria - Peoria
- Arizona Center for Cancer Care - Deer Valley - Phoenix
- Arizona Center for Cancer Care - Osborne - Scottsdale
- Arizona Center for Cancer Care - Shea - Scottsdale
- Arizona Center for Cancer Care - Surprise - Surprise
- Southern Arizona VA Health Care System - Tucson
Florida
- 21st Century Oncology - Fort Lauderdale
- 21st Century Oncology - Lakewood Rch
- 21st Century Oncology - Naples
- 21st Century Oncology - Plantation
- Clinical Research Center of Florida - Pompano Beach
Colorado
- Valley View Hospital - Glenwood Springs
- Colorado Clinical Research - Lakewood
- Advanced Urology - Parker
California
- VA Northern California Health Care System - Mather
- Precision Radiation Oncology - Tustin
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 711 participants |
| Start Date | 2011-09 |
| Est. Completion | 2030-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01436968
The ClinicalTrials.gov registry entry for NCT01436968 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 711 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (17% higher). The listed sponsor is Candel Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Aglatimagene besadenovec + valacyclovir is the first listed.
NCT01436968 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Arizona, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT01436968 about?
NCT01436968 is a clinical study titled "Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer". 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 stimul...
What is the current status of trial NCT01436968?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 711 participants. The study started on 2011-09. Estimated completion is 2030-12.
What conditions does trial NCT01436968 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01436968?
The interventions under investigation include: Aglatimagene besadenovec + valacyclovir (BIOLOGICAL), Placebo + valacyclovir (BIOLOGICAL).
Who is sponsoring clinical trial NCT01436968?
This trial is sponsored by Candel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01436968 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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