Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer

NCT05597852 | Recruiting DMC

• 1 other identifier: FIRST STAR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of SpaceOAR

  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;

  5 year

Secondary Outcomes (6)

• Acute and late cumulative incidence of toxicities

  5 years

• Quality of Life using EPIC

  5 years

• Biochemical disease-free survival

  5 years

• Use of salvage ADT

  18 Months

• Health utilities

  5 years

Study Arms (1)

Study Arm

EXPERIMENTAL

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.

Device: SpaceOAR

Interventions

SpaceOAR DEVICE

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

Study Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only male patients with Prostate Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Amandeep Taggar, MD

  Sunnybrook

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandeep Taggar, MD

CONTACT

416 480 6165; aman.taggar@sunnybrook.ca

Andrea DeAbreu

CONTACT

416 480 5000; Andrea.Deabreu@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with local recurrence of prostate cancer with previous irradiation will have a hydrogel spacer, SpaceOAR™ inserted.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 28, 2022
• Study Start: November 30, 2021
• Primary Completion: November 30, 2022
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

CA (1)