RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2018-02-27

Study Completion:2029-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03424850

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

Hiram A Gay, M.D.

CONTACT

314-362-8516

hiramgay@wustl.edu

Principal Investigator

Hiram A Gay, M.D.

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Hiram A Gay, M.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-02-27

Study Completion Date2029-02-28

Study Record Updates

Study Start Date2018-02-27

Study Completion Date2029-02-28

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer
Prostate Neoplasm