Prostate Cancer
Conditions
Keywords
Radiotherapy, prostate cancer, treatment, radiation
Brief summary
A number of recent studies have successfully reduced the number of radiotherapy treatments used for prostate cancer from 39 daily treatments to as little as 5 treatments. This study is designed to determine how tumors inside the prostate respond during these 5 treatments on magnetic resonance imaging (MRI) and use that information to design 2 fraction radiotherapy treatments for prostate cancer. For these two fraction treatments, the first fraction of radiation will use extra radiation to any nodules in the prostate, and the second fraction of radiation will give extra radiation to the nodule(s) in the prostate based on how those nodules responded to the first fraction of radiation. This idea is a relatively old concept but has not been used in the treatment of cancer yet. This research includes a clinical trial that evaluates whether it is safe to design treatments like this.
Interventions
RADIATIONradiotherapy
External beam radiotherapy via stereotactic body radiotherapy (SBRT).
Sponsors
AHS Cancer Control Alberta
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a prospective open label, phase II, two-arm, sequentially allocated non-inferiority cohort trial. This trial design is necessary to determine the multi-parametric magnetic resonance imaging (mpMRI) based treatment response thresholds necessary to inform the DAPAR dose received by patients in the second arm. The first arm and first phase of the study will enroll 25 patients to receive MR imaging-based evaluations of response to 5 fractions of once weekly prostate stereotactic body radiotherapy (SBRT) to a total dose of 4000cGy to the prostate and proximal seminal vesicles and 3625cGy in 5 fractions to a planning target volume (PTV) margin of 3-5mm. The MR response measurements will then be used to deliver 2300cGy in 2 fractions to a PTV margin of 3-5mm around the prostate and proximal seminal vesicles and between 2500cGy and 2900cGy in 2 fractions to the MR based dominant intraprostatic lesion (DIL), delivered 3 weeks apart.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the prostate * NCCN risk grouping of intermediate or high risk prostate cancer * Patients must be 18 years of age, or older on the day of signing informed consent and be willing and able to provide written informed consent/assent * Identifiable lesion within the epithelium of the prostate as determined by the treating radiation oncologist * Have a prostate imaging reporting and data system (PIRADS) 4 or 5 nodule noted on MRI * Have not received prior pelvic radiotherapy * Life expectancy greater than 10 years * ECOG performance status \<3 * Eligible for SBRT to the prostate
Exclusion criteria
* No identifiable lesion within the prostate on 3T MRI * Prior trans-urethral resection of the prostate * Non-adenocarcinoma histology * Meeting criteria for very high-risk risk or node positive prostate cancer * Active inflammatory bowel disease * Evidence of metastatic disease on CT or bone scan * Declined radiotherapy * Unlikely to be available for all follow-up appointments * Having received androgen deprivation therapy or 5-alpha reductase therapy prior to trial therapy * Extensive disease in the posterior prostate or aberrant anatomy that makes the safe delivery of boost irradiation not feasible * Unable to understand or sign a study consent form after use of interpreter if required * Has a relative contraindication to radiotherapy including systemic lupus erythematosus, TNM deficiency or scleroderma * Unable to tolerate or ineligible for mpMR imaging * Any condition or diagnosis, that could in the opinion of the treating physician or qualified investigator interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence | Baseline 3 weeks (includes treatment period for Arm 1 and 2) 1 month (includes treatment period for Arm 1) 3 months 6 months 2 years | Cumulative incidence of acute common terminology criteria for adverse events (CTCAE) v6.0 ≥ grade 2 genitourinary (GU) toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence | Baseline 3 weeks 1 month 3 months 6 months 2 years | Cumulative incidence of acute CTCAE v6.0 ≥ grade 2 gastrointestinal (GI) toxicity |
| international index of erectile function (IIEF-5) | Baseline 3 weeks 1 month 3 months 6 months 2 years | IIEF-5 is a 5-item questionnaire (with a 1- 5 score for each item, 1 being the lowest or worst and 5 the highest/best) used to diagnose erectile disfunction. |
| expanded prostate cancer index composite (EPIC) | 1 month and 2 years post treatment | EPIC is a questionnaire designed to measure Quality of Life issues in patients with Prostate cancer. Overall GU domain is scored from 1 to 5 with 1 being "No problem" and 5 being "Big problem" |
| EPIC GI | 1 month and 2 years post treatment | EPIC GI is about bowel habits and abdominal pain and has an overall score of1 - 5 with 1 being "No problem" and 5 being "Big problem" |
| PSA | 2 years post treatment | Proportion of patients with PSA \<0.4ng/mL at 2 years post treatment |
| PSA nadir | 2 years post treatment | Absolute PSA nadir at 2 years post treatment (all therapy) |
| MRI | treatment week 3 | MRI based radiographic response of DIL at on treatment week 3 |
| MRI response | 6 months post treatment | MRI based radiographic response at 6 months post treatment |
Countries
Canada
Contacts
CONTACTCharlie Kirkby
CONTACTAsongna Folefoc
Outcome results
None listed