Prostate Cancer
Conditions
Keywords
Prostate cancer, Radiotherapy, Hypofractionation, Africa, Acute toxicity, Late toxicity, Treatment outcome
Brief summary
Hypofractionated radiotherapy (HFRT) is a technique that delivers a higher radiation dose per treatment fraction over a shorter overall number of fractions, thus reducing the number of radiotherapy visits required to complete a course of radiation therapy. HFRT significantly alleviates the burden of transportation, accommodation, and income loss for patients while mitigating the strain on already limited healthcare personnel and infrastructure resources. Several randomized studies conducted in Europe and the USA have demonstrated that HFRT for prostate cancer is non-inferior to conventional radiotherapy in terms of toxicity and treatment outcomes. HypoAfrica Prostate Cancer is a multi-center study that aims to explore the feasibility of implementing moderate HFRT for the treatment of localized prostate cancer in Africa. In particular, this study will evaluate the gastrointestinal and genitourinary toxicities in prostate cancer patients for up to two years post-completion of HFRT.
Detailed description
Rationale: Radiotherapy is a critical and inseparable component of cancer treatment but access to radiotherapy is significantly inadequate in low-and middle-income countries. Adopting hypofractionated regimens as standard of care for prostate cancer offers logistical advantages by reducing the burden on the already strained radiotherapy resources in most African countries and increasing patient convenience. Several large randomized, phase 3 trials from high-income Western countries offer level I evidence to implement moderate hypofractionation for prostate cancer, providing control and toxicity similar to that of conventionally delivered fractionation. The present study will explore the feasibility of applying moderate hypofractionated radiotherapy for prostate cancer in a low- or middle- income country setting in sub-Saharan Africa. Objective: To explore the feasibility of applying moderate hypofractionation for localized prostate cancer in an African setting. Study design: This is a multi-centre, prospective, observational study to be conducted at 3 sites across Africa. Subject enrollment is anticipated to be completed in approximately 12 months. Subjects will be followed for up to 5 years from enrollment. Study population: Patients with localized non-metastatic prostate cancer. Intervention: Hypofractionated radiation therapy. Patients will be treated with 20 daily fractions, 5 times/week. Toxicity will be measured using the European Organization for Research and Treatment of Cancer-Radiation Therapy Oncology Group modified toxicity scores (EORTC-RTOG) and the Common Terminology Criteria for Adverse Events (CTCAE), version 5.
Interventions
RADIATIONHypofractionated radiotherapy for low- and intermediate-risk prostate cancer patients
Hypofractionated radiotherapy for low- and intermediate-risk prostate cancer will be treated with 20x3 Gray (Gy), 5 days/week
RADIATIONHypofractionated radiotherapy for high-risk prostate cancer patients
Hypofractionated radiotherapy for high-risk prostate cancer will be treated with 20x3.1 Gy, 5 days/week
Sponsors
Inkosi Albert Luthuli Central Hospital
Erasmus Medical Center
Dana-Farber Cancer Institute
Nigeria Sovereign Investment Authority-Lagos University Teaching Hospital Cancer Center (NLCC)
Muhimbili University of Health and Allied Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Histologically confirmed localized (low-intermediate-high risk) prostate cancer 2. Any T stage, any prostate specific antigen (PSA) value, any Gleason score, lymph node negative, non-metastatic (N0M0), based on computed tomography (CT) scan or magnetic resonance image (MRI), bone scintigraphy, and/or positron emission tomography prostate-specific membrane antigen (PET-PSMA) scan. 3. Willing to provide informed consent. 4. Willing to participate in post-treatment follow-up at 3, 12, and 24 months post-treatment.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Radiological evidence of pelvic nodal disease (CT scan, MRI, PET-PSMA scan) 2. Presence of distant metastasis (bone scintigraphy, PET-PSMA scan) 3. Patient is a candidate for elective lymph node irradiation 4. Inflammatory bowel disease 5. Previous pelvic radiotherapy 6. Previous prostatectomy 7. Bilateral hip prostheses 8. Unwilling to participate in post-treatment follow-up at 3, 12, and 24 months post-treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade ≥2 acute gastro-intestinal and genitourinary toxicity at the end of radiotherapy | 27-30 days from start of radiotherapy | Toxicity measured using European Organization for Research and Treatment of Cancer-Radiation Therapy Oncology Group modified toxicity scores (EORTC-RTOG) and the Common Terminology Criteria for Adverse Events (CTCAE), version 5 |
| Cumulative grade ≥2 late gastro-intestinal and genitourinary toxicity 3-24 months after radiotherapy | 3-24 months post radiotherapy | Toxicity measured using European Organization for Research and Treatment of Cancer-Radiation Therapy Oncology Group modified toxicity scores (EORTC-RTOG) and the Common Terminology Criteria for Adverse Events (CTCAE), version 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any grade gastro-intestinal and genitourinary toxicity at 3-12-24 months | 3, 12, and 24 months post radiotherapy | Toxicity measured using European Organization for Research and Treatment of Cancer-Radiation Therapy Oncology Group modified toxicity scores (EORTC-RTOG) and the Common Terminology Criteria for Adverse Events (CTCAE), version 5 |
| PSA failure-free survival at 5 years | 5 years post-radiotherapy | — |
Other
| Measure | Time frame |
|---|---|
| Overall survival at 5 years | 5 years post-radiotherapy |
| Number of patients lost-to-follow-up | 5 years post-radiotherapy |
Countries
Nigeria, South Africa, Tanzania
Outcome results
None listed