Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 43 of 1449 for:    prostate cancer AND radiation

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02280356
Recruitment Status : Active, not recruiting
First Posted : October 31, 2014
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: external beam radiation therapy Radiation: brachytherapy Behavioral: questionnaires Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultra-hypofractionated, Image-guided, Intensity-modulated Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer
Actual Study Start Date : October 28, 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 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 (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
Other Names:
  • International Prostate Symptom Score
  • International Index of Erectile Function-6
  • EPIC urinary, bowel and sexual domain




Primary Outcome Measures :
  1. late urinary toxicity assessed by CTCAE v4.0 [ Time Frame: 12 months ]
    at approximately 12 months of hypofractionated radiation therapy in combination with brachytherapy for the treatment of intermediate risk prostate cancer.


Secondary Outcome Measures :
  1. International Prostate Symptom Score (IPSS) to assess urinary functioning [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280356


Locations
Layout table for location information
United States, New Jersey
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memorial Sloan Kettering Nassau (Follow Up Only)
Uniondale, New York, United States, 11553
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Marisa Kollmeier, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02280356     History of Changes
Other Study ID Numbers: 14-193
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
Radiation Therapy
Brachytherapy
14-163
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases