NCT05597852 Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer
| NCT ID | NCT05597852 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2021-11-30 |
| Primary Completion | 2022-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2021-11-30 with a primary completion date of 2022-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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)
Contact & Investigator
Amandeep Taggar, MD
PRINCIPAL INVESTIGATOR
Sunnybrook
Frequently Asked Questions
Who can join the NCT05597852 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05597852 currently recruiting?
Yes, NCT05597852 is actively recruiting participants. Contact the research team at aman.taggar@sunnybrook.ca for enrollment information.
Where is the NCT05597852 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05597852 clinical trial?
NCT05597852 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Amandeep Taggar, MD at Sunnybrook. The trial plans to enroll 10 participants.
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