Clinical trial NCT04197141: Hypofractionated Whole-Pelvis Radiotherapy (WPRT) vs Conventionally-Fractionated WPRT in Prostate Cancer
Official title: Is Hypofractionated Whole-Pelvis Radiotherapy (WPRT) as Well Tolerated as Conventionally-Fractionated WPRT in Prostate Cancer Patients? (HOPE-Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Unfavorable intermediate risk
High risk
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Association of Radiation Oncology
name: AbbVie
First posted: 2019-12-12
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quality of Life (QOL) - late bowel function as measured by the EPIC questionnaire
timeFrame: I year post treatment (approximately 3 years and 2 months)
Secondary outcomes:
measure: Quality of Life - acute urinary and sexual QOL as measured by the EPIC questionnaire
timeFrame: 6 weeks post treatment (approximately 2 years and 3 months)
measure: Quality of Life - acute bowel toxicity as measured by the EPIC questionnaire
timeFrame: 6 weeks post treatment (approximately 2 years and 3 months)
measure: Quality of Life - late bowel bother as measured by the EPIC questionnaire
timeFrame: I year post treatment (approximately 3 years and 2 months)
measure: Quality of Life - late urinary and sexual QOL as measured by the EPIC questionnaire
timeFrame: I year post treatment (approximately 3 years and 2 months)
measure: International Prostate Symptom Score (IPSS)
timeFrame: 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)
measure: Toxicity - urinary, bowel, and sexual as measured by CTCAE version 4.0
timeFrame: 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)
measure: Prostatic Specific Antigen (PSA) curve
timeFrame: 4 years post treatment (approximately 6 years and 2 months)
measure: Prostatic Specific Antigen (PSA) Nadir
timeFrame: 4 years post treatment (approximately 6 years and 2 months)
measure: Cost Effectiveness of Hypofractionated WPRT
timeFrame: End of study (approximately 7 years and 2 months)
measure: Overall Survival
timeFrame: End of study (approximately 7 years and 2 months)
measure: Biochemical Failure-Free Survival
timeFrame: End of study (approximately 7 years and 2 months)
measure: Freedom from Local Failure
timeFrame: End of study (approximately 7 years and 2 months)
measure: Freedom from Regional Failure
timeFrame: End of study (approximately 7 years and 2 months)
measure: Androgen Deprivation Therapy Free Survival
timeFrame: End of study (approximately 7 years and 2 months)
measure: Metastasis Free Survival
timeFrame: End of study (approximately 7 years and 2 months)
measure: Prostate Cancer Free Survival
timeFrame: End of study (approximately 7 years and 2 months)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer
state: British Columbia
city: London
country: Canada
facility: London Regional Cancer Program of the Lawson Health Research Institute
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Lucas C Mendez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.