Hypofractionated Whole-Pelvis Radiotherapy (WPRT) vs Conventionally-Fractionated WPRT in Prostate Cancer

NCT04197141 | Active Not Recruiting Phase 2

• 1 other identifier: HOPE Trial
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this research study is to determine if 5 (five) fractions of external radiotherapy with higher radiation doses per fraction to the pelvis leads to similar results to the standard of care external radiotherapy treatment that is comprised of 25 fractions of external radiotherapy with lower radiation doses per fraction to the pelvis. This study aims to investigate the impact in quality of life associated with hypofractionated Whole Pelvis Radiotherapy (WPRT) in comparison to conventionally-fractionated WPRT in patients with unfavorable-intermediate and high-risk prostate cancers. This information is valuable as hypofractionated WPRT is a more attractive and convenient treatment approach, and may become the new standard of care if proven to be well-tolerated and effective. Therefore, this study aims to provide a more rational justification for use of hypofractionated WPRT in future larger randomized trials by comparing this strategy with the current standard of care. This study will also provide an initial understanding of the toxicity profile and cancer control associated with hypofractionated WPRT and High Dose Rate Brachytherapy (HDR-BT).

Conditions

Prostate Cancer

Keywords

Unfavorable intermediate risk; High risk

Outcome Measures

Primary Outcomes (1)

• Quality of Life (QOL) - late bowel function as measured by the EPIC questionnaire

  Late bowel function as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC) sub-domain approximately 1 year after the end of treatment. The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The values vary from 0 to 100 for each question. The scores can then be added to come up with an overall quality of life score.

  I year post treatment (approximately 3 years and 2 months)

Secondary Outcomes (16)

• Quality of Life - acute urinary and sexual QOL as measured by the EPIC questionnaire

  6 weeks post treatment (approximately 2 years and 3 months)

• Quality of Life - acute bowel toxicity as measured by the EPIC questionnaire

  6 weeks post treatment (approximately 2 years and 3 months)

• Quality of Life - late bowel bother as measured by the EPIC questionnaire

  I year post treatment (approximately 3 years and 2 months)

• Quality of Life - late urinary and sexual QOL as measured by the EPIC questionnaire

  I year post treatment (approximately 3 years and 2 months)

• International Prostate Symptom Score (IPSS)

  6 weeks post treatment (approximately 2 years and 3 months), 1 year post treatment (approximately 3 years and 2 months) and 2 years post treatment (approximately 4 years and 2 months)

Study Arms (2)

Conventionally-fractionated WPRT

ACTIVE COMPARATOR

15 Gy HDR brachytherapy boost will be administered followed by 45 Gy WPRT in 25 fractions. Androgen Deprivation Therapy (ADT) may also be prescribed at the discretion of the treating physician.

Radiation: Conventionally-fractionated WPRT

Hypofractionated WPRT

EXPERIMENTAL

15 Gy HDR brachytherapy boost will be administered followed by 25 Gy WPRT in 5 fractions. Androgen Deprivation Therapy (ADT) may also be prescribed at the discretion of the treating physician.

Radiation: Hypofractionated WPRT

Interventions

Conventionally-fractionated WPRT RADIATION

Total dose: 45 Gy in 25 fractions WPRT

Conventionally-fractionated WPRT

Hypofractionated WPRT RADIATION

Total dose: 25 Gy in 5 fractions WPRT

Hypofractionated WPRT

Eligibility Criteria

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

You may qualify if:

• Age 18 or older
• Study Informed Consent provided
• Pathologically proven diagnosis of prostatic adenocarcinoma
• Unfavorable intermediate risk \[with greater than 15% chance of node involvement based on Memorial Sloan Kettering Cancer Center (MSKCC) nomogram https://www.mskcc.org/nomograms/prostate\] or high or very-high-risk prostate cancer based on National Comprehensive Cancer Network (NCCN) classification \[Prostatic Specific Antigen (PSA) \> 20 ng/mL or clinical cT3a or cT3b or Gleason 8-10\]
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• No prior history of pelvic irradiation, brachytherapy, cryosurgery, High-Intensity Focused Ultrasound (HIFU), Transurethral Resection of the Prostate (TURP) or radical prostatectomy

You may not qualify if:

• Presence of nodal or distant metastasis, as confirmed by Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) of the chest/abdomen/pelvis and bone scan within 45 days of randomization
• Plan for adjuvant docetaxel post-radiotherapy
• Serious medical comorbidities or other contraindications to HDR-BT
• Presence of inflammatory bowel disease
• Presence of connective tissue disease
• Medically unfit for general anesthesia
• Unable or unwilling to complete questionnaires

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canadian Association of Radiation Oncology: collaborator
• AbbVie: collaborator

Study Sites (3)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

BC Cancer

Kelowna, British Columbia, V1Y 5L3, Canada

Location

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

• Mendez LC, Arifin AJ, Bauman GS, Velker VM, Ahmad B, Lock M, Venkatesan VM, Sexton TL, Rodrigues GB, Chen J, Schaly B, Warner A, D'Souza DP. Is hypofractionated whole pelvis radiotherapy (WPRT) as well tolerated as conventionally fractionated WPRT in prostate cancer patients? The HOPE trial. BMC Cancer. 2020 Oct 9;20(1):978. doi: 10.1186/s12885-020-07490-0.

  PMID: 33036579 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Lucas C Mendez, MD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 12, 2019
• Study Start: February 7, 2020
• Primary Completion: March 1, 2024
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)