Hypofractionation for Prostate Cancer in Africa: A Feasibility Study (HypoAfrica)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Hypofractionated radiotherapy for low- and intermediate-risk prostate cancer patients; Radiation: Hypofractionated radiotherapy for high-risk prostate cancer patients

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.

• Study Type: Observational
• Enrollment (Actual): 182

Contacts and Locations

Study Locations

• Nigeria
  • Lagos, Nigeria
    • NSIA-LUTH Cancer Center
• South Africa
  • Durban, South Africa
    • Inkosi Albert Luthuli Central Hospital
• Tanzania
  • Dar es Salaam, Tanzania
    • Ocean Road Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with localized prostate cancer undergoing treatment at the trial sites

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low-intermediate risk; Men with localized prostate cancer - T1c-T3a, Gleason <8	Radiation: Hypofractionated 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
High-risk; Men with localized prostate cancer - T3b-T4 and/or Gleason ≥8	Radiation: Hypofractionated radiotherapy for high-risk prostate cancer patients; Hypofractionated radiotherapy for high-risk prostate cancer will be treated with 20x3.1 Gy, 5 days/week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade ≥2 acute gastro-intestinal and genitourinary toxicity at the end 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	27-30 days from start of radiotherapy
Cumulative grade ≥2 late gastro-intestinal and genitourinary toxicity 3-24 months after 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	3-24 months post radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any grade gastro-intestinal and genitourinary toxicity at 3-12-24 months	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	3, 12, and 24 months post radiotherapy
PSA failure-free survival at 5 years		5 years post-radiotherapy

Other Outcome Measures

Outcome Measure	Time Frame
Overall survival at 5 years	5 years post-radiotherapy
Number of patients lost-to-follow-up	5 years post-radiotherapy

Collaborators and Investigators

• Sponsor: Muhimbili University of Health and Allied Sciences
• Collaborators: Dana-Farber Cancer Institute; Erasmus Medical Center; Inkosi Albert Luthuli Central Hospital; Nigeria Sovereign Investment Authority-Lagos University Teaching Hospital Cancer Center (NLCC)

Publications and helpful links

General Publications

• Olatunji E, Swanson W, Patel S, Adeneye SO, Aina-Tofolari F, Avery S, Kisukari JD, Graef K, Huq S, Jeraj R, Joseph AO, Lehmann J, Li H, Mallum A, Mkhize T, Ngoma TA, Studen A, Wijesooriya K, Incrocci L, Ngwa W. Challenges and opportunities for implementing hypofractionated radiotherapy in Africa: lessons from the HypoAfrica clinical trial. Ecancermedicalscience. 2023 Feb 16;17:1508. doi: 10.3332/ecancer.2023.1508. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2021
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Prostate cancer; Radiotherapy; Africa; Treatment outcome; Hypofractionation; Acute toxicity; Late toxicity
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HypoAfrica Prostate Cancer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No