Trial Outcomes & Findings for Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer (NCT NCT02280356)

Last Updated: 2024-03-04

Results Overview

Participants with Urinary Toxicity Assessed by CTCAE v4.0 at approximately 12 months of hypofractionated radiation therapy in combination with brachytherapy for the treatment of intermediate risk prostate cancer.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

12 months

Results posted on

2024-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Radiation Therapy in Combination With Brachytherapy Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy to the prostate \& seminal vesicles.
Overall Study STARTED	45
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiation Therapy in Combination With Brachytherapy Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy to the prostate \& seminal vesicles.
Overall Study Not Treated	2
Overall Study Withdrawal by Subject	1
Overall Study Not evaluable	2

Baseline Characteristics

Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation Therapy in Combination With Brachytherapy n=45 Participants Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy to the prostate \& seminal vesicles.
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 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	3 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	5 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Radiation Therapy in Combination With Brachytherapy n=45 Participants Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy to the prostate \& seminal vesicles.
Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0	33 Participants

SECONDARY outcome

Timeframe: 12 months

The International Prostate Symptom Score/IPSS index is a seven item questionnaire that assesses urinary functioning, including urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale. Higher scores indicate more difficulty in urinary functioning. A score of 7 or less is mildly symptomatic, 8 to 19 is moderately symptomatic, and 20 to 35 is severely symptomatic. Scale range is 0-35. Total score is reported.

Outcome measures

Outcome measures
Measure	Radiation Therapy in Combination With Brachytherapy n=45 Participants Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy to the prostate \& seminal vesicles.
Mean Change in International Prostate Symptom Score (IPSS) to Assess Urinary Functioning From Baseline at 12 Months	5 scores on a scale Interval 0.0 to 18.0

Adverse Events

Radiation Therapy in Combination With Brachytherapy

Serious events: 0 serious events

Other events: 33 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Radiation Therapy in Combination With Brachytherapy n=45 participants at risk Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy to the prostate \& seminal vesicles.
Renal and urinary disorders Urinary frequency	73.3% 33/45 • 1 year
Renal and urinary disorders Urinary urgency	68.9% 31/45 • 1 year
Respiratory, thoracic and mediastinal disorders Erectile dysfunction	57.8% 26/45 • 1 year
General disorders Fatigue	17.8% 8/45 • 1 year
Renal and urinary disorders Urinary incontinence	15.6% 7/45 • 1 year
Renal and urinary disorders Urinary tract obstruction	13.3% 6/45 • 1 year
Renal and urinary disorders Urinary tract pain	13.3% 6/45 • 1 year
Gastrointestinal disorders Rectal hemorrhage	11.1% 5/45 • 1 year
Renal and urinary disorders Renal and urinary disorders - Other, specify	11.1% 5/45 • 1 year
Gastrointestinal disorders Diarrhea	8.9% 4/45 • 1 year
Gastrointestinal disorders Proctitis	8.9% 4/45 • 1 year

Additional Information

Dr. Marisa Kollmeier, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-3952

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place