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Trial Title:
High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer
NCT ID:
NCT05754580
Condition:
Prostatic Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
High Dose Brachytherapy
Description:
This technique involves transient insertion of a stronger (i.e. more active) source
(Ir-192) into the prostate, with dose delivery over the course of several minutes
followed by immediate removal.
Arm group label:
High Dose Rate (HDR) Brachytherapy and Stereoscopic Body Radiation (SBRT) treatment
Other name:
HDR Brachytherapy
Intervention type:
Radiation
Intervention name:
Stereostatic Body Radiation Therapy
Description:
ultra-hypofractionation radiation therapy.
Arm group label:
High Dose Rate (HDR) Brachytherapy and Stereoscopic Body Radiation (SBRT) treatment
Other name:
SBRT
Summary:
The objective of this phase I/II trial is to prospectively evaluate the toxicity and
therapeutic efficacy of Stereostatic Body Radiation Therapy (SBRT) to prostate and pelvic
lymph nodes in combination with high-dose-rate (HDR) brachytherapy to the prostate in
patients with localized unfavorable-intermediate risk or higher disease.
Detailed description:
Currently the practice of minimizing monetary and human costs of therapy in the field of
oncology is in vogue. As such, there has been heightened interest in the ability to
decrease the total number and duration of radiation therapy treatments via brachytherapy
and stereotactic body radiation therapy (SBRT). With this, the use of SBRT has been
increasingly utilized for elective nodal irradiation (ENI) to treat patients with
intermediate-risk prostate cancer or higher to improve biochemical progression free
survival (bPFS). However, there is a dearth of studies assessing the efficacy and
toxicity profile of these two modalities in combination. The objective of this phase I/II
trial is to prospectively evaluate the toxicity and therapeutic efficacy of SBRT to
prostate and pelvic lymph nodes in combination with high-dose-rate (HDR) brachytherapy to
the prostate in patients with localized unfavorable-intermediate risk or higher disease.
We hypothesize that this combination therapy will have an acceptable toxicity profile and
that ENI via SBRT will provide improved bPFS compared to no nodal treatment and
synonymous with conventional fractionation. The sample size will be 53 patients, with
biopsy confirmed unfavorable-intermediate or higher risk prostate cancer and ≥ 15%
probability of nodal involvement as determined by publicly available nomograms. Eligible
patients will undergo ultrasound-guided HDR brachytherapy to the whole prostate to a dose
of 15 Gy in 1 fractions followed by SBRT to a dose of 25 Gy in 5 fractions given every
other day. Follow-up will assess toxicity and biochemical progression-free survival and
subsequent comparison to historical results.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histopathologically proven diagnosis of local unfavorable intermediate or higher
risk prostate cancer as defined by NCCN risk group criteria. Biopsies will be
confirmed by UNMC pathology review if collected outside our institution.
2. No prior definitive treatment or intervention received.
3. Life expectancy of more than 10 years as estimated by the treating physician.
4. Negative evaluation lymph node involvement or distant metastatic disease on
abdominopelvic CT, prostate MRI, and/or PSMA PET.
5. Negative evaluation of osseous metastatic disease via bone scan or PSMA PET scan.
6. Greater than or equal to 15% nodal involvement risk predicated on publicly available
MSKCC pre-prostatectomy nomogram.
7. Karnofsky performance status ≥ 80 within 30 days prior to registration.
8. Age ≥ 19 years.
9. Clinically determined to be a candidate for HDR brachytherapy.
10. Patient must be able to provide study-specific informed consent prior to study
entry.
Exclusion Criteria:
1. American Urological Association Urinary Symptom Score (AUA score) ≥ 15.
2. Large prostate volume relative to pelvic arch width that can hinder proper placement
of applicator insertion. To be done by MRI, TRUS, and/or physical exam for size, by
CT A/P or MRI for arch interference. Specifically, prostates must be no greater than
75 cc in size as decerned by MRI, TRUS, or physical exam. Potential for pubic arch
interference will be decerned by the treating radiation oncologist based on MRI
and/or CT imaging.
3. Presence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule.
4. Relative or absolute contraindications to radiation therapy as determined by the
treating physician. These include, but not limited to, inflammatory bowel disease,
connective tissue disorders (systemic lupus erythematosus, scleroderma, etc.),
genetic disorders that risk increase sensitivity to radiation therapy.
5. Medical conditions that, in the opinion of the investigator could compromise patient
safety.
6. Prior invasive malignancy other than prostate cancer (except non-melanomatous skin
cancer) unless disease free for a minimum of 1 year.
7. History of rectal surgeries.
8. Recent major surgical procedure, open biopsy, or significant traumatic injury within
30 days prior to registration.
9. History of Urolift.
10. Contraindications to general anesthesia.
11. Preexisting rectal fistula.
Gender:
Male
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather D Mittelstedt, RN
Phone:
402-559-8278
Email:
hmittelstedt@unmc.edu
Start date:
August 29, 2023
Completion date:
October 2026
Lead sponsor:
Agency:
University of Nebraska
Agency class:
Other
Source:
University of Nebraska
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05754580
