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

NCT02280356 | Completed Phase 2 Results

• 1 other identifier: 14-193
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Prostate Cancer

Keywords

Radiation Therapy; Brachytherapy; 14-163

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Change in International Prostate Symptom Score (IPSS) to Assess Urinary Functioning From Baseline at 12 Months

  12 months

Study Arms (1)

radiation therapy in combination with brachytherapy

EXPERIMENTAL

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 (25Gy in 5 fractions; 5Gy x 5 fractions every other day) to the prostate \& seminal vesicles. Both brachytherapy as well as external beam will be performed according to our current standards of practice using the same equipment, techniques, \& treatment planning procedures. Pts will be followed post-treatment at 1, 3, 6 (+/- 4 weeks) \& every 6 months (+/- 4 weeks) thereafter until 36 months. During the post-treatment followup, pts will be evaluated for urinary, bowel/rectal \& sexual toxicity. Baseline measures of these domains will be obtained prior to treatment at the time of enrollment. Serum PSA levels will be drawn on the same schedule as clinical followup. Post-treatment prostate biopsies will be obtained once between 24-36 months post-treatment to evaluate pathologic response to therapy

Radiation: external beam radiation therapy; Radiation: brachytherapy; Behavioral: questionnaires

Interventions

external beam radiation therapy RADIATION

radiation therapy in combination with brachytherapy

brachytherapy RADIATION

radiation therapy in combination with brachytherapy

questionnaires BEHAVIORAL

Also known as: International Prostate Symptom Score, International Index of Erectile Function-6, EPIC urinary, bowel and sexual domain

radiation therapy in combination with brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (6)

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Location

Memorial Sloan Kettering Nassau (Follow Up Only)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Marisa Kollmeier, MD
• Organization: Memorial Sloan Kettering Cancer Center

KollmeiM@mskcc.org

212-639-3952

Study Officials

• Marisa Kollmeier, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: October 31, 2014
• Study Start: October 28, 2014
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2023-01

Locations

US (6)