Recruiting

Rectal Hydrogel Spacer

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05597852

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SpaceOAR

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT05597852

Start date

Nov 30, 2021

Status verified date

Oct, 2022

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Study Arm

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.

Interventions

SpaceOAR

SpaceOAR hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life.

Primary outcome measure

  • Feasibility of SpaceOAR [ Time Frame: 5 year ]

Central Contacts and Locations

Locations

Sunnybrook Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Amandeep Taggar, MD

416 480 6165

Principal Investigator:

Andrew Loblaw, MD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Oct 28, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2022-10-28.