Clinical trial · Interventional
Early Investigation of High Precision Radiotherapy Prior to Commencing Standard Radiotherapy for Prostate Cancer
Phase I Dose Escalation Study of Stereotactic BOOST for Prostate cancER
- 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)
Current standard treatment for prostate cancer involves giving patients approximately 40 doses of radiotherapy, one dose per day over an 8 week period. The purpose of this study is to assess the effects of giving two separate high doses of a special type of precision radiotherapy to the prostate and then 5 weeks (instead of 8 weeks) of standard radiotherapy. Hypothesis: It is safe to give patients an extra two doses of high-precision radiotherapy prior to commencing a shorter period of standard radiotherapy for 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 |
|---|---|---|---|
| Dose escalation using stereotactic boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation using stereotactic boost
- description
- Dose level allocation - Participants will be allocated to the current dose level, or if the current dose level has been filled and acceptable toxicity has been established, they will be enrolled into the next dose level
- interventionNames
- Radiation: Dose escalation using stereotactic boost
Primary outcomes (1)
- measure
- Acute toxicity
- timeFrame
- Assessed up to 12 weeks post treatment.
- description
- Portion of patients with grade 3 or greater genitourinary or gastrointestinal toxicity assessed using the Modified Radiation Therapy Oncology Group (RTOG) Toxicity Scale.
Secondary outcomes (4)
- measure
- Late toxicity
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven prostate adenocarcinoma * PSA obtained within three months prior to enrollment. * International Prostate Symptom Score (I-PSS) score \<15 * No contraindication to MRI (pacemaker, severe claustrophobia) * Patient must be able to have fiducial markers placed in the prostate (if on anticoagulants, must be cleared by LMO or cardiologist). * ECOG performance status 0-2 * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Previous pelvic radiotherapy * Prior total prostatectomy * Unwilling or unable to give informed consent * Unwilling or unable to complete quality of life questionnaires.
References
Publications (0)
Data not yet available