Prostate Cancer
Conditions
Brief summary
Adult male patients with high-risk, localized prostate cancer and planning to undergo radiation therapy (RT) with androgen deprivation therapy (ADT) will undergo an advanced Magnetic Resonance Imaging (MRI) examination called Restriction Spectrum Imaging (RSI-MRI) to evaluate whether RSI-MRI can predict treatment response.
Detailed description
Participants will undergo RSI at three time points: before therapy (MRI #1), after neoadjuvant ADT (MRI #2), and after radiotherapy (MRI #3). Treatment response will be assessed primarily by absence of biochemical recurrence (PSA ≥2 ng/mL greater than nadir) within 3 years of completing radiotherapy. Change in RSI cellularity index from MRI #1 to MRI #2 will be evaluated for prediction of participants who will experience biochemical recurrence within 3 years, using area under the receiver operating characteristic curve. We hypothesize that RSI cellularity index will be an early biomarker for treatment effectiveness in prostate cancer treated with ADT and radiotherapy.
Interventions
OTHERRestriction Spectrum Imaging Magnetic Resonance Imaging
RSI is a multicompartment model of diffusion MRI that uses data acquired at multiple b-values to distinguish varied diffusion speeds (restricted intracellular, hindered extracellular, and approximately free diffusion).
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
A logistic regression model of biochemical recurrence within 3 years will be fit, using maximum likelihood, on the change in RSI cellularity index from MRI #1 to MRI #2 and relevant covariates such as demographics. Continuous variables will be splined; only main effects will be considered. The cross-validated Area Under the Curve (AUC) for this model will be reported with a 95% bootstrap confidence interval using Efron's bias-corrected and accelerated (bca) method. If the lower bound on the 95% confidence interval of the Area Under the Curve (AUC) excludes 0.55, RSI cellularity index will be declared viable for identifying participants who will recur within the three-year post treatment. If declared viable, a Cox model for predicting recurrence time will be fit, and the hazard ratios for RSI will be used to describe the adjusted associations supported by the data between RSI cellularity index and recurrence time.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male, aged ≥18 years, with histologically confirmed adenocarcinoma of the prostate * High-risk prostate cancer (any of: PSA ≥20 ng/mL or cT3-T4 stage or Gleason score ≥8) * Intended treatment and follow-up according to standard of care for prostate cancer * Planning to undergo definitive radiotherapy with neoadjuvant and concurrent androgen deprivation therapy * In good general health as evidenced by medical history and Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion criteria
* Prior radiotherapy to the pelvis * Prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy) * Hip prosthesis * Contraindication to MRI, per institutional requirements * Technetium-99 bone scan showing no clear evidence of distant metastasis * MRI or CT scan of the pelvis showing no clear evidence of bone or distant metastasis * Another malignancy, unless in remission or unlikely to impact the patient's survival or ability to receive standard care for prostate cancer (e.g., cutaneous basal cell carcinoma) * Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical recurrence (PSA 2 ng/mL greater than nadir) within 3 years of completing RT. | within 3 years of RT completion | To evaluate the performance of the RSI cellularity index before and during therapy as a biomarker to identify participants who will experience biochemical recurrence within 3 years post-radiotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSA nadir within the 18 months after RT ≥0.5 ng/mL. | within 18 months of RT completion | To evaluate the performance of the RSI cellularity index for identifying participants who will fail to reach a PSA nadir \<0.5 ng/mL within 18 months of RT. |
Countries
United States
Outcome results
None listed