Clinical trial · Observational
Hypofractionation for Prostate Cancer in Africa: A Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated radiotherapy for high-risk prostate cancer patients | Radiation | — | UNRESOLVED |
| Hypofractionated radiotherapy for low- and intermediate-risk prostate cancer patients | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Low-intermediate risk
- description
- Men with localized prostate cancer - T1c-T3a, Gleason \<8
- interventionNames
- Radiation: Hypofractionated radiotherapy for low- and intermediate-risk prostate cancer patients
- label
- High-risk
- description
- Men with localized prostate cancer - T3b-T4 and/or Gleason ≥8
- interventionNames
- Radiation: Hypofractionated radiotherapy for high-risk prostate cancer patients
Primary outcomes (2)
- measure
- Grade ≥2 acute gastro-intestinal and genitourinary toxicity at the end of radiotherapy
- timeFrame
- 27-30 days from start of radiotherapy
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDOlatunji 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