Hypofractionation for Prostate Cancer in Africa: A Feasibility Study

NCT06950307 | Active Not Recruiting

• 1 other identifier: HypoAfrica Prostate Cancer
• Study Type: observational
• Target: 182
• Locations: 3 countries
• Sites: 3

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Radiotherapy; Hypofractionation; Africa; Acute toxicity; Late toxicity; Treatment outcome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  3, 12, and 24 months post radiotherapy

• PSA failure-free survival at 5 years

  5 years post-radiotherapy

Other Outcomes (2)

• Overall survival at 5 years

  5 years post-radiotherapy

• Number of patients lost-to-follow-up

  5 years post-radiotherapy

Study Arms (2)

Low-intermediate risk

Men with localized prostate cancer - T1c-T3a, Gleason \<8

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

High-risk

Men with localized prostate cancer - T3b-T4 and/or Gleason ≥8

Radiation: Hypofractionated radiotherapy for high-risk prostate cancer patients

Interventions

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

Low-intermediate risk

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

High-risk

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with localized prostate cancer undergoing treatment at the trial sites

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

NSIA-LUTH Cancer Center

Lagos, Lagos, Nigeria

Location

Inkosi Albert Luthuli Central Hospital

Durban, South Africa

Location

Ocean Road Cancer Institute

Dar es Salaam, Tanzania

Location

Related Publications (1)

• 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.

  PMID: 37113724 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Muhimbili University College of Health Sciences Research Chair Holder

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 30, 2025
• Study Start: December 30, 2021
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

TA (1); NG (1); ZA (1)