Recruiting
Phase 2

Ultra-Hypofractionated Radiotherapy

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05851547

Conditions

Prostatic Neoplasms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prostate SBRT with Focal Boost

Triptorelin Injection

Study Details

Brief summary:

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.

Conditions

Prostatic Neoplasms

Study ID

NCT05851547

Start date

Nov 23, 2023

Status verified date

Jan, 2024

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

54 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prostate SBRT with Focal Boost and Androgen Deprivation Therapy

Stereotactic body radiotherapy to 27 Gy in 3 fractions to uninvolved regions of the prostate glad and up to 39 Gy in 3 fractions to mpMRI-defined intraprostatic lesions, with concurrent/adjuvant androgen deprivation therapy (6 months for intermediate risk, 24 months for high risk)

Interventions

Prostate SBRT with Focal Boost

Prostate stereotactic body radiotherapy delivered to 27 Gy in 3 fractions on alternating days to uninvolved regions with up to 39 Gy in 3 fractions delivered to mpMRI-defined intraprostatic lesions

Triptorelin Injection

Six months of androgen deprivation therapy for intermediate-risk localized prostate cancer and 24 months for high-risk localized prostate cancer

Primary outcome measure

  • Genitourinary and gastrointestinal toxicity [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Scott Grimes

613-737-7700sgrimes@ohri.ca

Locations

The Ottawa Hospital Cancer Centre

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Scott Grimes

6137377700sgrimes@ohri.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jan 5, 2024

Last verified

Jan, 2024

Keywords

  • Localized Prostate Cancer
  • Intermediate Risk
  • High Risk
  • Stereotactic Body Radiotherapy
  • External Beam Radiotherapy
  • Hypofractionation
  • Focal Boost
  • Microboost
  • Androgen Deprivation Therapy
  • Multiparametric magnetic resonance imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2024-01-05.