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Recruiting NCT03424850

Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy

Phase I / Phase II Interventional Prostate Cancer Prostate Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HDR brachytherapy.
Who it may be relevant to
Registry conditions: Prostate Cancer, Prostate Neoplasm. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase I/II Dose-escalation Study Evaluating the Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy

Overview

The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.

Interventions

  • Radiation HDR brachytherapy
    * Dose constraints for 21 Gy: * Bladder and rectum: V70 \< 1 cc * Urethra: V115 \< 1 cc * V135: 0% * Dose constraints for 23 Gy: * Bladder and rectum: V65 \< 1 cc * Urethra: V105 \< 1 cc * V125: 0% * Dose constraints for 25 Gy: * Prostate V100 \>90% (\>95% preferred) * Bladder and rectum: V70 \< 1 cc, Dmax \<115% * Urethra: V110 \< 1 cc, Dmax \<120%

Primary outcome measures

  • Biochemical control experienced by patients with prostate cancer treated with an HDR implant [Time frame: Through 3 years after implant]
Secondary outcome measures (2)
  • Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant [Time frame: From start of treatment through 90 days]
  • Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant [Time frame: From day 91 through 3 years after implant]

Eligibility criteria

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of early stage prostate cancer.
  • Must be considered either low-risk (T1-T2a, Gleason ≤ 6, PSA < 10 ng/mL) or favorable intermediate-risk (Gleason 3 +4 = 7, percentage of positive biopsy cores < 50%, no more than one NCCN intermediate risk factor).
  • Prior androgen deprivation therapy is allowed and may have been initiated up to 6 months prior to the date of the HDR implant. The complete duration of androgen deprivation therapy can range from 4 months to 36 months provided it has been initiated no more than 6 months prior to the date of the HDR implant.
  • At least 18 years of age.
  • ECOG performance status ≤ 2
  • Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion criteria

  • Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.
  • A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only.
  • Currently receiving any other investigational agents.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • Unable to undergo general, spinal or local anesthesia.
  • Prior TURP with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT03424850 · 201801118

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗