NCT05597852Recruiting
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 · Last updated 28 Oct 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 17 Oct 2022
- Start date
- 30 Nov 2021
- Primary completion date
- 30 Nov 2022
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Prostate cancer
- NCT number
- NCT05597852
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 30 Nov 2021 to the primary completion date, 30 Nov 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticoagulation medication (if unsafe to discontinue)
- Prior ultra-hypofractionated radiotherapy ( SBRT of 5Gy/fraction or higher)
Other illness
- Diagnosis of bleeding diathesis
- Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
Other
- Contraindication to prostate MRI
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Odette Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.