Hypofractionation for Prostate Cancer in Africa: A Feasibility Study

Active, not recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06950307
• Lead Sponsor: Muhimbili University of Health and Allied Sciences

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.

Study Timeline

• Study Start: 2021-12-30
• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 182

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

NSIA-LUTH Cancer Center; 🇳🇬 Lagos, Nigeria

Inkosi Albert Luthuli Central Hospital; 🇿🇦 Durban, South Africa

Ocean Road Cancer Institute; 🇹🇿 Dar es Salaam, Tanzania