Trial Outcomes & Findings for Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer (NCT NCT01354951)

Last Updated: 2018-10-19

Results Overview

focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

6 months to 2 years

Results posted on

2018-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Prostate Biopsy, Focal Brachytherapy , Assessment of QOL This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prostate Biopsy, Focal Brachytherapy , Assessment of QOL n=3 Participants This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months to 2 years

Population: Data not collected

focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 and 24 months

Population: Data not collected

as measured by the ability to obtain all negative biopsy cores 12 and 24 months after completion of therapy in the hemi-gland of where the focal therapy was administered. "All negative" means no prostate cancer;

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment

Population: Data not collected

Following focal brachytherapy in patients with early stage low volume localized prostate cancer. The scales to measure these domains were derived from the previously validated MSKCC Prostate-Health Related Quality of Life Questionnaire (PHRQOLQ

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Data not collected

Post-treatment MRI outcome is defined as a 3-level categorical variable: positive, negative and undetermined. Post-treatment biopsy outcome is defined as a binary variable: positive and negative. We will examine the correlation between the 12-month MRI and 12-month biopsy, and between the 24-month MRI and 24-month biopsy. The correlation will be assessed by a Fisher exact test.

Outcome measures

Outcome data not reported

Adverse Events

Prostate Biopsy, Focal Brachytherapy , Assessment of QOL

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Prostate Biopsy, Focal Brachytherapy , Assessment of QOL n=3 participants at risk This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
Gastrointestinal disorders Fecal incontinence	33.3% 1/3 • 24 months
Renal and urinary disorders Urinary frequency	33.3% 1/3 • 24 months
Renal and urinary disorders Urinary urgency	33.3% 1/3 • 24 months
Metabolism and nutrition disorders Hyperglycemia	33.3% 1/3 • 24 months
Investigations Alanine aminotransferase increased	33.3% 1/3 • 24 months

Additional Information

Dr. Michael Zelefsky, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-6802

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place