The goal of this clinical trial is to evaluate if adaptive stereotactic body radiation therapy (SBRT) is a safe and effective way to treat prostate cancer in adults. It will assess the safety profile of adaptive SBRT over time.
The main questions this trial aims to answer are:
* What is highest dose of adaptive SBRT without causing serious side effects? * Can adaptive SBRT more precisely targeting the prostate while reducing radiation exposure to nearby organs? * What side effects do participants experience during treatment, right after treatment, and over the five years post-treatment? * Can adaptive SBRT reduce urination-related side effects and support quality of life during and after treatment?
Participants will:
* Receive adaptive SBRT treatment every other day, for a total of 5 treatment sessions (called fractions). The full course of treatment typically takes 2 to 3 weeks. * Have a follow-up phone call about 6 weeks after treatment to check on side effects and overall wellbeing. * Visit the clinic for check-ups and tests:
* At 90 days (about 3 months) after treatment * Then every 3 months for the first year * Then every 6 months after that
Subjects must have histologically confirmed intermediate- and favorable high risk (AJCC 8th ed stage IIA-IIC) adenocarcinoma of the prostate.
Age > 18 years.
ECOG performance status ≤ 2
Prostate volume (segmented) ≤ 100 cc determined by MRI and/or US within 24 mo of treatment for patients not on ADT and within 6 mo for patients on prior ADT. A simulation MRI is acceptable.
Subjects must not be experiencing toxicity CTCAE grade ≥ 3 GU or GI toxicity at baseline.
Subjects must not be receiving any other investigational agents.
Subjects must not have had prior pelvic radiation therapy.
Subjects must not have node-positive disease.
Single group
adaptive stereotactic body radiation therapy (SBRT) with a SIB
RadiationThis is a phase 1 dose finding study investigating escalated doses of adaptive prostate SBRT for patients with intermediate and favorable high risk prostate cancer. There will be a Bayseian Optimal Interval Design (BOIN) defining the dose escalation parameters and the dose will escalate as per Section 5.0. Treatment is 5 fractions every other day and will be expected to be typically completed in 2-3 calendar weeks.
Severe (CTCAE grade ≥ 3) treatment-related (possibly, probably or definitely) toxicity occurring within 90 days of treatment.
Biochemically progression free survival
Time from the end of treatment administration to biochemical progression (using Pheonix definition), local, regional, or distant progression, initiation of additional prostate cancer therapy, or death. Patients who are alive and have not experienced any progression or initiated any additional prostate cancer therapy by the end of follow up are considered censored.
Local failure free survival
Time from the end of treatment administration to local progression or death. Patients who are still alive and have not had local progression by the end of follow up are considered censored.
PSA response
The PSA response will be assessed by the post-treatment PSA nadir and time to nadir.
The proportion of patients who have a decrease greater than or equal to the acute minimum clinically important difference (MID) in EPIC-26 scores among the urinary, bowel and sexual function domains at 3 and 6 months post-treatment compared to baseline
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