Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-120
SponsorNational Cancer Institute (NCI)
About this trial
Background:
The current standard treatment of prostate cancer is either surgery or radiation. Typically, this includes either the removal or radiation of the whole prostate gland. Many people now seek out focal therapy options to decrease the side effects of treatment. Until now, several forms of physical destruction with heat (thermal ablation), cold (cryotherapy), sound waves (HIFU), laser (FLA), and electrical energy (IRE). A new type of radiation (SBRT) may be an effective way to cure men of early-stage prostate cancer with fewer side effects than standard treatments.
Objective:
To see how people with untreated localized prostate cancer will respond to focal therapy with SBRT.
Eligibility:
People aged 18 years and older with untreated localized prostate cancer (prostate cancer which has not spread outside of the prostate gland).
Design:
* Participants will undergo screening including blood tests, an MRI, a PSMA PET/CT (18F-DCFPyL), and a biopsy. * Small, non-radioactive, gold seeds about the size of a grain of rice will be placed in and/or around the tumor to help target the radiation treatment. * Radiation (SBRT) will occur in 2 separate sessions about 1 week apart. No sedation is used, these sessions are painless. Each session will take about 1-2 hours. Participants can go home afterwards. * Follow-up will continue for 2 years with repeat scans (MRI and PSMA PET/CT) and blood (PSA) tests. * After two years, a biopsy will be done to understand the impact of this new treatment on prostate cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have histologically confirmed, low or intermediate risk prostatic adenocarcinoma verified by biopsy (NIH Laboratory of Pathology confirmation is required).
Unifocal prostate cancer defined as a single focus of prostate cancer on MRI and PSMA PET/CT imaging which is correlated with a positive targeted biopsy.
Age >=18 years.
ECOG performance status <=2 (Karnofsky >60%).
Disqualifiers
Participants with NCCN high-risk prostate cancer features (Gleason score >=8, >cT2c, or PSA >= 20 ng/mL).
Participants with prostate biopsies which show >= grade group 2 adenocarcinoma determined to be outside of the radiographically visible lesion (systematic biopsies which map to a radiographically detected lesion are not an exclusion criterion).
Participants in whom concurrent systemic Androgen Deprivation Therapy (ADT) or chemotherapy is planned.
Participants who are receiving any other investigational agents.
Trial design
Design model
Single group
Treatments tested in this trial
18F-DCFPyL
DrugEach participant will receive a single IV dose of 18F-DCFPyL by bolus injection. The target administered activity will be 6.5 mCi with a lower limit of 6 mCi; dose variations will be in accordance with the Nuclear Regulatory Commission (NRC) standard dose variation (i.e., 20%) permitted for diagnostic clinical studies.
Stereotactic Body Radiation Therapy
RadiationIntensity modulated radiotherapy will be delivered to a dose of 26Gy in two fractions with the second fraction performed within 8 days of the first session.
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: 1/Focal SBRTExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Pathologic complete response rate
The primary objective of this trial is to determine the pathologic complete response rate on biopsy at two years in patients undergoing focal SBRT for prostate cancer. This will be defined by a negative biopsy at 2 years post-treatment.
Time frame
2 yearsSecondary outcomes
1
Longitudinal quality of life (QoL)
The QoL scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model quality of life scores at baseline, during and after treatment. Changes of QoL scores from baseline at each timepoint treatment will be calculated from the estimated linear mixed effect model.
Time frame
baseline and 1, 3, 6, 9, 12, 15, 18, 21, and 24 months after focal SBRT2
PSA kinetics
The PSA kinetics scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model PSA kinetics at baseline, during and after treatment. Changes of PSA kinetics during and after treatment will be calculated from the estimated linear mixed effect model. In the rare case where PSA test is done on outside laboratory assay, a sensitivity analysis will be conducted to analyze PSA kinetics with and without outside values to determine whether outside laboratory measurement influenced results.
Time frame
1 week and 1, 3, 6, 9, 12, 15, 18, 21, 24 months after focal SBRT3
Nadir PSA
The nadir PSA (time to nadir PSA and value of nadir PSA) will be described for this cohort (median, mean, standard deviation, and range).
Time frame
1 week and 1, 3, 6, 9, 12, 15, 18, 21, 24 months after focal SBRT4
Absolute and relative fraction of free PSA to bound PSA
Descriptive statistics for the absolute amount and relative fraction of free PSA and bound PSA at the various timepoints detailed in 10.1 will be reported will be compared with baseline by paired Wilcoxon test.
Time frame
1 week and 1, 3, 6, 9, 12, 15, 18, 21, 24 months after focal SBRTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov