Clinical trial · Interventional
Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer
Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer (pHART 3)
NCT01578902CI-TRIAL-00048912pHART3completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (35 Gy / 5 fractions / 29 days) for the treatment of low-risk prostate cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic ablative body radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated radiotherapy using SABR
- description
- Stereotactic radiation: 35Gy in 5 fractions over 29 days
- interventionNames
- Radiation: Stereotactic ablative body radiotherapy
Primary outcomes (1)
- measure
- Incidence of Grade 3+ Gastrointestinal Toxicity
- timeFrame
- Acute period (up to 6 months)
- description
- Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Secondary outcomes (5)
- measure
- Incidence of Grade 3+ Genitourinary Toxicity
- timeFrame
- Acute (up to 6 months) and Late (6 months and after)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent signed (Appendix A) * Adult men greater than 18 years of age * Histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally reviewed). * Clinical stage T1-T2b, Gleason Score \< 6, and PSA \< 10 ng/mL * Less than 50% of biopsy cores +ve for cancer * Less than 50% overall surface area involved with cancer * Neoadjuvant hormone suppression therapy is allowed. However, PSA, must have been performed within 2 months of starting androgen suppression therapy. If androgen suppression therapy has been started LHRH agonist must be continued for a minimum of 3 months before initiation of gold fiducial marker insertion \& radiotherapy planning. Exclusion Criteria: * Prior pelvic radiotherapy. * Concurrent anticoagulation medication (if it is unsafe to discontinue for gold seed insertion) * Diagnosis of bleeding diathesis * Presence of a hip prosthesis * Pelvic girth \>40cm (to ensure visibility of gold seeds on electronic portal imaging device) * Large prostate (\> 60 cm3) on imaging * Severe lower urinary tract symptoms (International Prostate Symptom Score \> 15 or nocturia \> 3)
References
Publications (1)
- DERIVEDQuon HC, Musunuru HB, Cheung P, Pang G, Mamedov A, D'Alimonte L, Deabreu A, Zhang L, Loblaw A. Dose-Escalated Stereotactic Body Radiation Therapy for Prostate Cancer: Quality-of-Life Comparison of Two Prospective Trials. Front Oncol. 2016 Aug 29;6:185. doi: 10.3389/fonc.2016.00185. eCollection 2016. PMID 27622157