Trial Outcomes & Findings for Internal Radiation Therapy in Treating Patients With Prostate Cancer (NCT NCT00573833)

Results Overview

Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as \> or = grade 3 NCI CTC toxicity

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

At scheduled 3 month intervals for one year

Results posted on

2017-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	HDR Brachytherapy 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days questionnaire administration quality-of-life assessment brachytherapy
Overall Study STARTED	23
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	HDR Brachytherapy 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days questionnaire administration quality-of-life assessment brachytherapy
Overall Study Not Treated	2

Baseline Characteristics

Internal Radiation Therapy in Treating Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HDR Brachytherapy n=21 Participants 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days questionnaire administration quality-of-life assessment brachytherapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: At scheduled 3 month intervals for one year

Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as \> or = grade 3 NCI CTC toxicity

Outcome measures

Outcome measures
Measure	HDR Brachytherapy n=21 Participants 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days questionnaire administration quality-of-life assessment brachytherapy
Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity	20 participants

PRIMARY outcome

Timeframe: Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)

urinary and rectal toxicity-see the adverse event tables

Outcome measures

Outcome measures
Measure	HDR Brachytherapy n=21 Participants 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days questionnaire administration quality-of-life assessment brachytherapy
Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity	21 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12 reported

Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the number of participants who return to normal erectile function (IIEF-EF domain score ≥26)

Outcome measures

Outcome measures
Measure	HDR Brachytherapy n=21 Participants 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days questionnaire administration quality-of-life assessment brachytherapy
Number of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12 reported

Quality of life will be assessed with the MSKCC prostate quality of life instrument. International prostate symptom score index (IPSS). The IPSS index is a seven item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale with higher scores indicating more difficulty in urinary functioning. This measure demonstrated a high internal consistency (Cronbach's alpha = 0.84) with excellent test-retest reliability (r = 0.92).

Outcome measures

Outcome measures
Measure	HDR Brachytherapy n=21 Participants 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days questionnaire administration quality-of-life assessment brachytherapy
Median International Prostate Symptom Total Score	5 scores on a scale Interval 2.0 to 13.0

Adverse Events

HDR Brachytherapy

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HDR Brachytherapy n=21 participants at risk 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days questionnaire administration quality-of-life assessment brachytherapy
Gastrointestinal disorders Esophagitis	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Hemorrhage, Esophagus	4.8% 1/21 • Number of events 1

Other adverse events

Other adverse events
Measure	HDR Brachytherapy n=21 participants at risk 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days questionnaire administration quality-of-life assessment brachytherapy
Gastrointestinal disorders Diarrhea	4.8% 1/21 • Number of events 1
Reproductive system and breast disorders Ejaculatory dysfunction	4.8% 1/21 • Number of events 1
Reproductive system and breast disorders Erectile dysfunction	23.8% 5/21 • Number of events 5
Metabolism and nutrition disorders Phosphate, low (hypophosphatemia)	4.8% 1/21 • Number of events 1
Renal and urinary disorders Renal/Genitourinary-Other Specify	4.8% 1/21 • Number of events 1
Renal and urinary disorders Urinary frequency/urgency	19.0% 4/21 • Number of events 6
Renal and urinary disorders Urinary retention (includ neurogenic bladder)	23.8% 5/21 • Number of events 6

Additional Information

Dr. Josh Yoshiya Yamada, Assistant Attending

Memorial Sloan Kettering Cancer Center

Phone: +1212-639-2950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place