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Trial Outcomes & Findings for Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound (NCT NCT02225925)

NCT ID: NCT02225925

Last Updated: 2023-03-13

Results Overview

Additional procedure time with the registered ultrasound and fluoroscopy system (RUF) in the intra-operative setting for implantation procedure

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

at time of implantation procedure

Results posted on

2023-03-13

Participant Flow

Participant milestones

Participant milestones
Measure
Dynamic Dosimetry Brachytherapy
Cohort treated with dynamic dosimetry brachytherapy
Overall Study
STARTED
45
Overall Study
COMPLETED
45
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dynamic Dosimetry Brachytherapy
n=45 Participants
Cohort treated with dynamic dosimetry brachytherapy
Age, Categorical
<=18 years
0 Participants
n=45 Participants
Age, Categorical
Between 18 and 65 years
16 Participants
n=45 Participants
Age, Categorical
>=65 years
29 Participants
n=45 Participants
Age, Continuous
68 years
n=45 Participants
Sex: Female, Male
Female
0 Participants
n=45 Participants
Sex: Female, Male
Male
45 Participants
n=45 Participants
Region of Enrollment
United States
45 Participants
n=45 Participants

PRIMARY outcome

Timeframe: at time of implantation procedure

Additional procedure time with the registered ultrasound and fluoroscopy system (RUF) in the intra-operative setting for implantation procedure

Outcome measures

Outcome measures
Measure
Dynamic Dosimetry Brachytherapy
n=45 Participants
Cohort treated with dynamic dosimetry brachytherapy
Procedure Time
30 minutes
Interval 14.0 to 45.0

SECONDARY outcome

Timeframe: up to 30 days post-treatment

Number of patients with all seeds reconstructed from fluoroscopy

Outcome measures

Outcome measures
Measure
Dynamic Dosimetry Brachytherapy
n=45 Participants
Cohort treated with dynamic dosimetry brachytherapy
Seed Reconstruction From Intra-operative Fluoroscopy
45 Participants

SECONDARY outcome

Timeframe: 30 days post-treatment

Population: Data was not collected to assess this outcome measure

Number of participants with seed reconstruction with RUF versus CT fused with MRI doses for Prostate D90 (dose received by 90% of prostate)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days post-treatment

Number of patients with prostate V100 (the percent of the postimplant MR/CT-based prostate volume that received at least 100% of dose) of 95% or greater

Outcome measures

Outcome measures
Measure
Dynamic Dosimetry Brachytherapy
n=45 Participants
Cohort treated with dynamic dosimetry brachytherapy
Impact of RUF System on Dosimetric Outcomes of Seed Placement as Assessed by Number of Patients With Prostate V100 of 95% or Greater
44 Participants

SECONDARY outcome

Timeframe: Treatment - 30 days

Mean difference of D90 (% of prescribed dose) between intra-operative RUF and standard CT/MRI based dosimetry

Outcome measures

Outcome measures
Measure
Dynamic Dosimetry Brachytherapy
n=45 Participants
Cohort treated with dynamic dosimetry brachytherapy
Mean Difference in D90 Between Intra-operative RUF and Standard CT/MRI Based Dosimetry
8 percentage of prescribed dose
Interval 6.0 to 10.0

SECONDARY outcome

Timeframe: Treatment - 30 days

Population: Data was not collected to assess this outcome measure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 30 days post-implant, semiannually post treatment until year 2 and then annually until year 5

Population: Data was not collected to assess this outcome measure

Change in Quality of Life measures based on International Prostate Symptom Score (range 0-35, higher score reflects lower quality of life), Sexual Health Inventory Score (1-25, lower score reflects lower quality of life), Epic-26 Bowel score (0-100, lower score reflects lower quality of life)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 5 years

PSA biochemical failure-free survival at last follow-up visit

Outcome measures

Outcome measures
Measure
Dynamic Dosimetry Brachytherapy
n=45 Participants
Cohort treated with dynamic dosimetry brachytherapy
Prostate Specific Antigen (PSA) Outcomes
45 Participants

Adverse Events

Dynamic Dosimetry Brachytherapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Song

Johns Hopkins University

Phone: 410-502-5875

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place