Clinical trial NCT03424850: Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Prostate Neoplasm
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Biochemical control experienced by patients with prostate cancer treated with an HDR implant
timeFrame: Through 3 years after implant
Secondary outcomes:
measure: Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant
timeFrame: From start of treatment through 90 days
measure: Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant
timeFrame: From day 91 through 3 years after implant
Other outcomes:
measure: Optimal dose of radiation
timeFrame: Through 3 months after completion of implant for all patients enrolled (estimated to be 5 years and 3 months)
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Hiram A Gay, M.D.
role: PRINCIPAL_INVESTIGATOR
References: