Randomized Trial of Suicide Gene Therapy and Prostate Cancer (ReCAP)
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|ClinicalTrials.gov Identifier: NCT00583492|
Recruitment Status : Completed
First Posted : December 31, 2007
Results First Posted : March 17, 2016
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: Ad5-yCD/mutTKSR39rep-ADP Radiation: IMRT||Phase 2|
This is a randomized, controlled trial that will test the hypothesis that replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IRMT)will improve freedom from failure (FFF) relative to 80 Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk profile.
The trial contains two treatment arms:
Arm 1- Gene Therapy + IMRT Arm 2- IMRT
The study will be stratified by clinical site and pre-treatment risk factors (e.g., % positive biopsy cores, Gleason score.
- Gleason score 5/6 AND PSA <10 ng/mL; AND >=50% positive biopsy cores
- (Gleason score 5/6 and PSA 10-20 ng/mL) OR (Gleason score 7 and PSA 0 - 20 ng/mL); AND <50% positive biopsy cores
- Gleason score 5/6 and PSA 10-20 ng/mL) OR (Gleason score 7 and PSA 0-20 ng/mL) AND >=50% positive biopsy cores.
An interim safety analysis (Interim Analysis 1) will be conducted after the first 21 patients in the investigational therapy arm, and a total of 42 subjects in both arms, have completed the 90 day toxicity assessment following randomization (phase 2 component). If, at this point, there are no safety concerns as determined by the Data and Safety Monitoring Board (DSMB), the trial will continue as a phase 3 study with two additional interim analyses (Interim Analyses 2 & 3). The primary analysis for treatment efficacy will be based on all randomized subjects.
To assess the relative efficacy of replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IMRT) versus 80 Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk profile. The primary endpoint is freedom from failure (FFF) (biochemical or clinical).
To assess the difference between the two treatment arms for:
- Acute (<= 90 days) and long-term (> 90 days) toxicity.
- Prostate biopsy status (12 cores) at 2 years.
- Freedom from distant metastases.
- Disease-specific and overall survival.
- Quality of life.
- Possible effect of gene therapy on PSA doubling time (PSADT) after PSA failure.
- Possible association between the primary and secondary outcomes and Ad5-yCD/mutTKSR39rep-ADP adenovirus persistence (as measured by adenoviral DNA in blood).
- Possible association between the primary and secondary outcomes and specific immunological endpoints including levels of circulating CD4+ and CD8+ T lymphocytes, T-cell proliferation response, cytotoxic T lymphocyte (CTL) response, and development of antibodies to prostate-specific antigens.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled Trial of Replication-Competent Adenovirus-Mediated Suicide Gene Therapy in Combination With IMRT Versus IMRT Alone for the Treatment of Newly-Diagnosed Prostate Cancer With an Intermediate Risk Profile|
|Study Start Date :||December 2007|
|Primary Completion Date :||September 2013|
|Study Completion Date :||September 2013|
Experimental: Ad5-yCD/mutTKSR39rep-ADP + IMRT
Gene Therapy + IMRT
Ad5-yCD/mutTKSR39rep-ADP (1 x 10^12 vp) on day 1 Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy
Active Comparator: IMRT Alone
IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
- Freedom From Biochemical/Clinical Failure (FFF) [ Time Frame: 5 years ]Biochemical/Clinical Failure was defined as PSA nadir plus 2 ng/mL
- Acute >= Grade 3 Treatment-related Toxicity [ Time Frame: 90 days ]This metric includes both expected and unexpected events Toxicities were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3
- Positive Prostate Biopsy at 2 Years [ Time Frame: 2 years ]
- Freedom From Distant Metastases [ Time Frame: 10 years ]
- Disease-specific Survival [ Time Frame: 10 years ]
- Decrease in Quality of Life [ Time Frame: 3 years ]Quality of Life was measured using the comprehensive Expanded Prostate Cancer Index Composite (EPIC) instrument 19 and 20
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583492
|United States, Maryland|
|Johns Hopkins University School of Medicine|
|Baltimore, Maryland, United States, 21231|
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Benjamin Movsas, M.D.||Henry Ford Health System|