Clinical trial NCT03458234: RAD 1801: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy
Official title: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Focal therapy
Prostate cancer
SBRT
Intra-urethral transponder
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2018-03-08
Enrollment: 5
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study offers focal therapy for prostate cancer by using an intra-urethral radiotransponder temporarily placed during radiotherapy. The study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time.

Detailed description: This study offers focal stereotactic body radiotherapy for prostate cancer by using an intra-urethral radiotransponder placed temporarily during each of the 5 radiotherapy treatments. The study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time while also accessing early efficacy, late toxicity, and overall quality of life post-treatment. Patients will be followed for 24 months (2 years) with follow-up appointments at 3, 6, 9, 12, 18, and 24 months.

Eligibility criteria: Inclusion Criteria:

* All patients must have histologically confirmed adenocarcinoma of the prostate, with biopsies obtained within 12 months of registration

  * Gleason score 3+3 or 3+4
  * PSA \<10 ng/mL within 3 months of enrollment
  * Clinical stage T1a-T2a by digital rectal exam
  * Up to 2 intraprostatic nodules visible on MRI, with combined volume \<50% of the total prostate volume
* Karnofsky Performance Status (KPS) \>70%.
* Life expectancy \>10 years
* Age ≥ 19 years
* Subjects given written informed consent

Exclusion Criteria:

* \>2 MRI defined nodules representing prostate cancer
* Total volume of MRI nodules exceeding 50% of total prostate volume
* Positive biopsy core in sextant region without MRI defined nodule (i.e. biopsy proven MRI occult prostate cancer)
* American Urological Association (AUA) urinary score ≥ 18.
* History of inflammatory bowel disease.
* Prior pelvic surgery
* Prior treatment for prostate cancer
* Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids is not considered an exclusion criteria.
* Platelet count \< 70,000/µL
* Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria.
* Contraindication to MRI such as implanted devices.
* Metallic pelvic implants resulting in imaging artifact within the prostate on MRI or CT

Primary outcomes:
measure: Confirm the Feasibility of Focal Prostate Stereotactic Body Radiotherapy (SBRT) With Real Time Guidance by Intra-urethral Radiotransponder Beacons.
timeFrame: 2 years
Secondary outcomes:
measure: Assess Early Efficacy
timeFrame: Within 6 months of completion of radiation therapy
measure: Assess Late Toxicity
timeFrame: Within 6 months of completion of radiation therapy
measure: Assess Quality of Life
timeFrame: Within 6 months of completion of radiation therapy
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Hazelrig-Salter Radiation Oncology Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Andrew M McDonald, MD
role: PRINCIPAL_INVESTIGATOR
References: