Dose Escalation For INtraprostatic LEsions

NCT05851547 | Recruiting Phase 2 DMC

• 1 other identifier: 20220698-01H
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Genitourinary and gastrointestinal toxicity

  Number of patients with grade 2 or greater genitourinary or gastrointestinal toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE ) version 5.0 and Radiation Therapy Oncology Group radiation toxicity scale

  Up to 2 years

Secondary Outcomes (2)

• Bowel and urinary quality of life

  Up to 2 years

• Disease-free survival

  2 years

Study Arms (1)

Prostate SBRT with Focal Boost and Androgen Deprivation Therapy

EXPERIMENTAL

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)

Radiation: Prostate SBRT with Focal Boost; Drug: Triptorelin Injection

Interventions

Prostate SBRT with Focal Boost RADIATION

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

Also known as: Ultrahypofractionated prostate radiotherapy with integrated microboost

Prostate SBRT with Focal Boost and Androgen Deprivation Therapy

Triptorelin Injection DRUG

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

Also known as: Androgen Deprivation Therapy

Prostate SBRT with Focal Boost and Androgen Deprivation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Knight Therapeutics (USA) Inc: collaborator

Study Sites (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate; Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Scott C Morgan, MD, MSc

  The Ottawa Hospital Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Grimes

CONTACT

613-737-7700; sgrimes@ohri.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prostate radiotherapy of 27 Gy in 3 fractions to uninvolved regions, up to 39 Gy in 3 fractions to mpMRI-defined intraprostatic lesions, with concurrent/adjuvant androgen deprivation therapy (6 months intermediate risk, 24 months for high risk)

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: May 9, 2023
• Study Start: November 23, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)