Status:
ACTIVE_NOT_RECRUITING
Hypofractionation for Prostate Cancer in Africa: A Feasibility Study
Lead Sponsor:
Muhimbili University of Health and Allied Sciences
Collaborating Sponsors:
Inkosi Albert Luthuli Central Hospital
Erasmus Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18-90 years
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 vi...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2029
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT06950307
Start Date
December 30 2021
End Date
March 1 2029
Last Update
April 30 2025
Active Locations (3)
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1
NSIA-LUTH Cancer Center
Lagos, Lagos, Nigeria
2
Inkosi Albert Luthuli Central Hospital
Durban, South Africa
3
Ocean Road Cancer Institute
Dar es Salaam, Tanzania