Clinical trial · Interventional
Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer
Feasibility of Integrating Rectal Hydrogel Spacer for Salvage Treatment Using Stereotactic Ablative Body Radiotherapy for Locally Recurrent 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)
There are several single institutional series that have reported their experience with salvage radiotherapy options that include EBRT, LDR and HDR brachytherapy. Gastrointestinal (GI) toxicity with salvage radiotherapy range between14-58%, respectively for patients undergoing re-irradiation. There is a concern for an increased risk of fistula development in these patients who receive second course of radiation. Hypofractionation using SABR has been utilized in the re-irradiation setting for prostate cancer with good tumor control and toxicity outcomes. In order to decrease the rectal toxicity, dose to the rectum should be kept as low as possible. Several techniques can be used to achieve this: tighter dosimetric dose painting, better patient or organ immobilization or use of a biodegradable gel. The Investigators ropose a phase I study to assess placement of a hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life.
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 |
|---|---|---|---|
| SpaceOAR | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Arm
- description
- All patients with local recurrence of prostate cancer post irradiation will undergo placement of a hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life prior to SABR.
- interventionNames
- Device: SpaceOAR
Primary outcomes (1)
- measure
- Feasibility of SpaceOAR
- timeFrame
- 5 year
- description
- To assess the feasibility, defined as successful placement in 70% of patients, of placing a hydrogel spacer, SpaceOAR™ in patients with biopsy confirmed locally recurrent prostate cancer, undergoing re-irradiation with hypofractionated external beam radiotherapy;
Secondary outcomes (6)
- measure
- Acute and late cumulative incidence of toxicities
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically and radiologically confirmed locally recurrent prostate adenocarcinoma * Willing to give informed consent to participate in this clinical trial * Able and willing to complete EPIC and EQ-5D questionnaires Exclusion Criteria: * Contraindication to prostate MRI * Anticoagulation medication (if unsafe to discontinue) * Diagnosis of bleeding diathesis * Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>20 * Evidence of castrate resistance (defined as PSA \> 3 ng/ml while testosterone is \< 0.7nmol/l). Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression. * Definitive extrapelvic nodal or distant metastatic disease on staging investigations. * Prior ultra-hypofractionated radiotherapy ( SBRT of 5Gy/fraction or higher)
References
Publications (0)
Data not yet available