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

Prostate Cancer Clinical Trial

Official title:

Ultra-hypofractionated, Image-guided, Intensity-modulated Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280356
• Other study ID #: 14-193
• Status: Completed
• Phase: Phase 2
• Start date: October 28, 2014
• Est. completion date: January 9, 2023

Study information

• Verified date: January 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the safety and side effects "of "ultra-hypofractionated" radiation therapy when used after brachytherapy (radiation implants). This treatment delivers a higher radiation dose with each treatment over a shorter period of time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 9, 2023
• Est. primary completion date: January 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Intermediate risk prostate cancer patients will be eligible for this study. Intermediate risk grouping will be assessed per NCCN guidelines as:

• Pathologically-proven diagnosis of prostate adenocarcinoma

• PSA 10-20ng/mL or

• Gleason =7 or

• Clinical stage T2b/c

• Clinical stage T2b/c Additionally, patients will be required to meet the following criteria

• Age =18

• KPS=70

• Prostate volume = 60cc (cytoreductive androgen deprivation therapy prior to brachytherapy of = 6 months duration will be allowed to achieve this goal). For patients with a prostate volume between 50-60ccs, hormone therapy will be at the discretion of the physician.

• International Prostate Symptom Score =15

Exclusion Criteria:

• Prior prostate surgery (including TURP)

• Prior history of chronic prostatitis or urethral stricture

• Inflammatory bowel disease

• Prior history of pelvic radiotherapy

• Unable to give informed consent

• Metastatic disease.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• external beam radiation therapy

• brachytherapy

Behavioral:
• questionnaires

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Suffolk	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering at Mercy Medical Center	Rockville Centre	New York
United States	Memorial Sloan Kettering Nassau (Follow Up Only)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0	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.	12 months
Secondary	Mean Change in International Prostate Symptom Score (IPSS) to Assess Urinary Functioning From Baseline at 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.	12 months

External Links

•   Memorial Sloan Kettering Cancer Center