NCT06950307Active, not recruiting
Hypofractionation for Prostate Cancer in Africa: A Feasibility Study
Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 182 (actual)
- First submitted
- 15 Apr 2025
- Start date
- 30 Dec 2021
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Muhimbili University of Health and Allied Sciences
- Diseases
- Prostate cancer
- NCT number
- NCT06950307
What you commit to
- Study type: Observational
- Participants enrolled: 182
- From 30 Dec 2021 to the primary completion date, 1 Mar 2026
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient is a candidate for elective lymph node irradiation
- Previous pelvic radiotherapy
- Previous prostatectomy
Other illness
- Radiological evidence of pelvic nodal disease (CT scan, MRI, PET-PSMA scan)
- Inflammatory bowel disease
Other
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Presence of distant metastasis (bone scintigraphy, PET-PSMA scan)
- Bilateral hip prostheses
- Unwilling to participate in post-treatment follow-up at 3, 12, and 24 months post-treatment
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NSIA-LUTH Cancer Center Coordinator of this site? Confirm its status | Lagos | Nigeria | Unknown status |
| Ocean Road Cancer Institute Coordinator of this site? Confirm its status | Dar es Salaam | Tanzania | Unknown status |
| Inkosi Albert Luthuli Central Hospital Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.