Trial Outcomes & Findings for Randomized Trial of Suicide Gene Therapy and Prostate Cancer (NCT NCT00583492)

Results Overview

Biochemical/Clinical Failure was defined as PSA nadir plus 2 ng/mL

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

5 years

Results posted on

2016-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Gene Therapy + IMRT Gene Therapy + IMRT Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one 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	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 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
Overall Study STARTED	21	23
Overall Study COMPLETED	21	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Trial of Suicide Gene Therapy and Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gene Therapy + IMRT n=21 Participants Gene Therapy + IMRT Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one 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	IMRT Alone n=23 Participants 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 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	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	23 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Biochemical/Clinical Failure was defined as PSA nadir plus 2 ng/mL

Outcome measures

Outcome measures
Measure	Gene Therapy + IMRT n=21 Participants Gene Therapy + IMRT Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one 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	IMRT Alone n=23 Participants 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 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
Freedom From Biochemical/Clinical Failure (FFF)	20 participants	21 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Gene Therapy + IMRT n=21 Participants Gene Therapy + IMRT Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one 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	IMRT Alone n=23 Participants 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 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
Acute >= Grade 3 Treatment-related Toxicity	4.6 percentage of adverse events	6.0 percentage of adverse events

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Gene Therapy + IMRT n=18 Participants Gene Therapy + IMRT Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one 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	IMRT Alone n=19 Participants 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 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
Positive Prostate Biopsy at 2 Years	6 participants	11 participants

SECONDARY outcome

Timeframe: 10 years

Outcome measures

Outcome measures
Measure	Gene Therapy + IMRT n=21 Participants Gene Therapy + IMRT Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one 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	IMRT Alone n=23 Participants 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 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
Freedom From Distant Metastases	21 participants	23 participants

SECONDARY outcome

Timeframe: 10 years

Outcome measures

Outcome measures
Measure	Gene Therapy + IMRT n=21 Participants Gene Therapy + IMRT Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one 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	IMRT Alone n=23 Participants 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 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
Disease-specific Survival	21 participants	23 participants

SECONDARY outcome

Timeframe: 3 years

Quality of Life was measured using the comprehensive Expanded Prostate Cancer Index Composite (EPIC) instrument 19 and 20

Outcome measures

Outcome measures
Measure	Gene Therapy + IMRT n=21 Participants Gene Therapy + IMRT Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one 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	IMRT Alone n=23 Participants 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 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
Decrease in Quality of Life	0 participants	0 participants

Adverse Events

Gene Therapy + IMRT

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

IMRT Alone

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gene Therapy + IMRT n=21 participants at risk Gene Therapy + IMRT Ad5-yCD/mutTKSR39rep-ADP: 1 x 10\^12 sterile injectable solution, 1 injection on day one 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	IMRT Alone n=23 participants at risk 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 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
Respiratory, thoracic and mediastinal disorders Flu-like symptoms	76.2% 16/21 • Number of events 16	4.3% 1/23 • Number of events 1
Hepatobiliary disorders Transaminitis	52.4% 11/21 • Number of events 11	8.7% 2/23 • Number of events 2
Blood and lymphatic system disorders Neutropenia	33.3% 7/21 • Number of events 7	4.3% 1/23 • Number of events 1
Blood and lymphatic system disorders Thrombocytopenia	47.6% 10/21 • Number of events 10	13.0% 3/23 • Number of events 3

Additional Information

Benjamin Movsas

Henry Ford Health System

Phone: 313-516-2319

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place