Clinical trial · Interventional
Low Dose Hemi-body Radiation For Recurrent Prostate Cancer
Non-Targeted Low Dose Radiotherapy For Recurrent Prostate Cancer
NCT03196778CI-TRIAL-00060244completedN/AClinicalTrials.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)
Older studies in animals and humans have shown cancer responses to very low doses of whole-body or hemi-body radiation. To study the effects of low doses of radiation in patients with recurrent prostate cancer, investigators will enroll up to 21 patients for 10 fractions of low dose radiation, delivered over 5 weeks. Participants will be followed on study for 12 months, capturing PSA, CBC, QoL and blood samples for immunological analysis.
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 |
|---|---|---|---|
| Low Dose Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Low Dose Radiation
- description
- Subjects will receive low dose body radiation for 5 weeks.
- interventionNames
- Radiation: Low Dose Radiotherapy
Primary outcomes (1)
- measure
- PSA response
- timeFrame
- Within 12 months of study treatment
- description
- Proportion of patients with a reduction of PSA levels by at least 50%
Secondary outcomes (3)
- measure
- Immunological changes
- timeFrame
- Within 12 months of study treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * A confirmed diagnosis of prostate cancer. * Having undergone prior prostate surgery or radiotherapy or both. * Evidence of recurrence of the disease as demonstrated by rising PSA levels. Patients are eligible if on androgen blockade or hormone naïve. Exclusion Criteria: * Prior treatment with chemotherapy and/or abiraterone and/or enzalutamide and/or radium-223. * Receiving treatment with immunosuppressive medications. * Platelet count below 50,000/µl (50 x 109/l) or leukocyte count below 3,000/µl (3 x 109/l) or granulocyte count below 2,000/µl (2 x 109/l). * Other medical conditions or co-morbidities which, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study. * Language difficulties which may hinder the patient's ability to complete the trial. * Inability of the potential participant to provide consent. * Lack of independence in daily living activities and any other conditions which, in the opinion of the Investigator, will hinder the participant's ability to participate and complete the study obligations.
References
Publications (1)
- DERIVEDKennedy AE, Dayes IS, Parpia S, Boreham DR, Bowdish DME. Characterizing Hematological Changes Following Repeated Exposure to Non-Targeted Low-Dose Ionizing Radiation in Prostate Cancer Patients. Dose Response. 2024 Oct 2;22(4):15593258241276120. doi: 10.1177/15593258241276120. eCollection 2024 Oct-Dec. PMID 39464181