Clinical trial NCT06950307: Hypofractionation for Prostate Cancer in Africa: A Feasibility Study
Official title: Hypofractionation for Prostate Cancer in Africa: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: Prostate cancer
Radiotherapy
Hypofractionation
Africa
Acute toxicity
Late toxicity
Treatment outcome
Lead sponsor: Muhimbili University of Health and Allied Sciences
Sponsor class: OTHER
Collaborators: name: Inkosi Albert Luthuli Central Hospital
name: Erasmus Medical Center
name: Dana-Farber Cancer Institute
name: Nigeria Sovereign Investment Authority-Lagos University Teaching Hospital Cancer Center (NLCC)
First posted: 2025-04-30
Enrollment: 182
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with localized prostate cancer undergoing treatment at the trial sites

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.

Eligibility criteria: 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

Primary outcomes:
measure: Grade ≥2 acute gastro-intestinal and genitourinary toxicity at the end of radiotherapy
timeFrame: 27-30 days from start of radiotherapy
measure: Cumulative grade ≥2 late gastro-intestinal and genitourinary toxicity 3-24 months after radiotherapy
timeFrame: 3-24 months post radiotherapy
Secondary outcomes:
measure: Any grade gastro-intestinal and genitourinary toxicity at 3-12-24 months
timeFrame: 3, 12, and 24 months post radiotherapy
measure: PSA failure-free survival at 5 years
timeFrame: 5 years post-radiotherapy
Other outcomes:
measure: Overall survival at 5 years
timeFrame: 5 years post-radiotherapy
measure: Number of patients lost-to-follow-up
timeFrame: 5 years post-radiotherapy
Locations:
city: Lagos
country: Nigeria
facility: NSIA-LUTH Cancer Center
city: Durban
country: South Africa
facility: Inkosi Albert Luthuli Central Hospital
city: Dar es Salaam
country: Tanzania
facility: Ocean Road Cancer Institute
Study officials:
References:
citation: 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.