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NCT Number: NCT06950307

Hypofractionation for Prostate Cancer in Africa: A Feasibility Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

NSIA-LUTH Cancer Center, Lagos, Nigeria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  • Histologically confirmed localized (low-intermediate-high risk) prostate cancer
  • 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.
  • Willing to provide informed consent.
  • 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:

  • Radiological evidence of pelvic nodal disease (CT scan, MRI, PET-PSMA scan)
  • Presence of distant metastasis (bone scintigraphy, PET-PSMA scan)
  • Patient is a candidate for elective lymph node irradiation
  • Inflammatory bowel disease
  • Previous pelvic radiotherapy
  • Previous prostatectomy
  • Bilateral hip prostheses
  • Unwilling to participate in post-treatment follow-up at 3, 12, and 24 months post-treatment

Treatment and study plan

Hypofractionated radiotherapy for low- and intermediate-risk prostate cancer patients

Radiation

Hypofractionated radiotherapy for low- and intermediate-risk prostate cancer will be treated with 20x3 Gray (Gy), 5 days/week

Hypofractionated radiotherapy for high-risk prostate cancer patients

Radiation

Hypofractionated radiotherapy for high-risk prostate cancer will be treated with 20x3.1 Gy, 5 days/week

Primary outcomes

  1. Grade ≥2 acute gastro-intestinal and genitourinary toxicity at the end of radiotherapy

    Time frame: 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

  2. Cumulative grade ≥2 late gastro-intestinal and genitourinary toxicity 3-24 months after radiotherapy

    Time frame: 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 outcomes

  1. Any grade gastro-intestinal and genitourinary toxicity at 3-12-24 months

    Time frame: 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

  2. PSA failure-free survival at 5 years

    Time frame: 5 years post-radiotherapy

Other outcomes

  1. Overall survival at 5 years

    Time frame: 5 years post-radiotherapy

  2. Number of patients lost-to-follow-up

    Time frame: 5 years post-radiotherapy

Sponsors and collaborators

Lead sponsor

Muhimbili University of Health and Allied Sciences

Other

Collaborators

  • Dana-Farber Cancer Institute
  • Erasmus Medical Center
  • Inkosi Albert Luthuli Central Hospital
  • Nigeria Sovereign Investment Authority-Lagos University Teaching Hospital Cancer Center (NLCC)

Registry information

Acronym: HypoAfrica

Important dates

Study start
2021
Primary completion
2026
Study completion
2029
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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