Dose Escalation For INtraprostatic LEsions

About This Trial

This study is for adults with localized prostate cancer that is considered intermediate or high risk and has not spread to other parts of the body.
Researchers are testing a shorter course of radiation that delivers higher, precisely targeted doses directly to the tumor in just three sessions over one week, instead of the usual daily treatments over four weeks.
The main goal is to see if this faster approach can effectively target the cancer without increasing bothersome bowel or urinary side effects.
Before joining, patients should know they must also receive standard hormone therapy, and those with prior pelvic radiation, hip replacements, or inflammatory bowel disease cannot participate.

External beam radiotherapy combined with androgen deprivation therapy is a standard treatment option for localized prostate cancer.
The current standard involves delivering radiotherapy uniformly throughout the prostate gland in daily fractions, five days per week, for approximately four weeks.
In this study, radiotherapy will be delivered using an ultra-hypofractionated approach in three larger fractions on alternating days over one week Multiparametric magnetic resonance imaging will be used to guide focal dose escalation to parts of the gland harboring tumor, which could potentially reduce the risk of cancer recurrence compared to standard dose of radiotherapy.
The aim of this study is to confirm that this approach can be delivered safely, that is, with rates of urinary and bowel side effects at 1 year of follow-up that are not significantly greater than the current standard.

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is for adults with localized prostate cancer that is considered intermediate or high risk and has not spread to other parts of the body.

Full Eligibility Criteria

Inclusion Criteria

Histologically confirmed adenocarcinoma of the prostate
Unfavourable intermediate-risk or high-risk localized disease
Unfavourable intermediate-risk prostate cancer is defined as intermediate-risk prostate cancer [that is, no high-risk features and one or more intermediate-risk factors: T2b-T2c, Gleason 3+4 (grade group 2) or Gleason 4+3 (grade group 3), or PSA 10-20 μg/L] and one or more of the following: 2 or 3 intermediate-risk factors; Gleason 4+3 (grade group 3); ≥ 50% biopsy cores positive
High-risk localized prostate cancer is defined as at least one of the following: T3a-T3b; Gleason ≥ 8 (grade group 4 or grade group 5); PSA > 20 μg/L
3 Tesla prostate MRI done no more than 12 months prior to enrollment
ECOG performance status 0-2
Age ≥ 18 years
Written informed consent
The participant has planned androgen deprivation therapy that meets one of the following criteria:
Patients with intermediate-risk localized prostate cancer who have planned androgen deprivation therapy consisting of up to 6 months of triptorelin with or without bicalutamide; OR patients with high-risk localized prostate cancer who have planned androgen deprivation therapy consisting of up to 24 months of triptorelin with or without bicalutamide.
Completion of all appropriate investigations prior to enrollment

Exclusion Criteria

Evidence of pelvic nodal metastases or distant metastases (AJCC Stage T1-4 N1 M0-1 or T1-4 N0 M1 disease)
Discordance between pre-enrollment prostate MRI and prostate biopsy findings, defined as biopsy cores with Gleason Gleason ≥ 4+3 (grade group ≥ 3) adenocarcinoma with no corresponding tumour focus seen on MRI
Androgen deprivation therapy commenced more than 60 days prior to enrollment
Intention to electively treat the pelvic lymph nodes with radiotherapy
Other active malignancy within the previous three years (except adequately treated nonmelanomatous carcinoma of the skin or low-grade superficial bladder carcinoma)
Prior pelvic radiotherapy
Contraindication to pelvic radiotherapy
Any history, past or present, of inflammatory bowel disease
Unilateral or bilateral hip arthroplasty
Trans-urethral resection of the prostate (TURP) performed within 6 months of anticipated start date of radiotherapy
Patients must not concurrently participate in any other therapeutic prostate cancer trial.