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Completed

NCT Number: NCT02280356

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering at Basking Ridge, Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

external beam radiation therapy

Radiation

Brachytherapy

Radiation

Questionnaires

Behavioral

Other names: International Prostate Symptom Score, International Index of Erectile Function-6, EPIC urinary, bowel and sexual domain

Primary outcomes

  1. Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0

    Time frame: 12 months

    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.

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2014
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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