Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer (FIRST STAR)

Feasibility of Integrating Rectal Hydrogel Spacer for Salvage Treatment Using Stereotactic Ablative Body Radiotherapy for Locally Recurrent Prostate Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: SpaceOAR

Detailed Description

Primary treatment of prostate cancer includes surgery or radiotherapy. Although significant improvements have been made in patient selection and treatment planning, local recurrence remains a common problem.

In the case of local recurrence after radiation, salvage options may include prostatectomy, salvage external beam radiotherapy (EBRT) or brachytherapy with low-dose (LDR) or high-dose rate (HDR) implantation, cryotherapy and high intensity focused ultrasound.

There are several single institutional series that have reported their experience with salvage radiotherapy options that include EBRT, LDR and HDR brachytherapy (2-7). Rates of grade 2 or higher genitourinary (GU) and gastrointestinal (GI) toxicity with salvage radiotherapy range between 36-50% and 14-58%, respectively for patients undergoing re-irradiation. GI Toxicity, however, is dependent on total rectal dose. This is especially important among patients who are being considered for re-irradiation. There is a concern for an increased risk of fistula development in these patients who receive second course of radiation although with salvage brachytherapy that risk was only 2% and seen only in patients who had a surgical intervention after salvage brachytherapy.

Hypofractionated regimens have become increasingly common in treatment of prostate cancer, especially with advancement of immobilization and imaging techniques that allow smaller margins and daily verification. Hypofractionation using SABR (Stereotatic Ablative Body Therapy) 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 objectives, dose painting, better patient or organ immobilization or use of a biodegradable gel. The latter has been used to increase the distance between the prostate and the rectum for patients who are undergoing prostate radiotherapy. Placement of a hydrogel spacer between the prostate and the rectum has been proven in a randomized controlled trial to reduce rectal dose resulting in decreased acute and long-term rectal toxicity and improvement in bowel-related quality of life. SpaceOAR is an FDA and Health Canada approved, commercially available rectal spacer that, when placed between the prostate and the rectum, has demonstrated to greatly reduce rectal dose and toxicity for patients undergoing external beam radiation and LDR brachytherapy.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amandeep Taggar, MD; Phone Number: 416 480 6165; Email: aman.taggar@sunnybrook.ca
• Study Contact Backup: Name: Andrea DeAbreu; Phone Number: 1058 416 480 5000; Email: Andrea.Deabreu@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Odette Cancer Centre
      • Contact: Amandeep Taggar, MD; Phone Number: 416 480 6165
      • Principal Investigator: Andrew Loblaw, MD
      • Sub-Investigator: Gerard Morton, MD
      • Sub-Investigator: Patrick Cheung, MD
      • Sub-Investigator: Danny Vesprini, MD
      • Sub-Investigator: Stanley Liu, MD
      • Sub-Investigator: William Chu, MD
      • Sub-Investigator: Hans Chung, MD
      • Sub-Investigator: Melanie Davidson, PhD
      • Sub-Investigator: Renee Korol, PhD
      • Sub-Investigator: Moti Paudel, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: SpaceOAR; SpaceOAR hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute and late cumulative incidence of toxicities	Acute and Late Cumulative incidence Using the CTCAE V5.0 for toxicities. Change of toxicity measured from Baseline	5 years
Quality of Life using EPIC	Acute and late quality of life using Expanded Prostate Index Composite (EPIC) Each question is scored from 1-5, 1 being the better outcome and 5 being the worst outcome.	5 years
Biochemical disease-free survival	PSA levels will checked for biochemical disease-free survival	5 years
Use of salvage ADT	Up to eighteen months of luteinizing-hormone releasing hormone agonists or antagonists can be used according to physician discretion.	18 Months
Health utilities	Health utilities using the EuroQol-5D (EQ-5D) Each question is scored from 1-5, 1 being the better outcome and 5 being the worst outcome.	5 years
Quality of Life using IPSS	Acute and late quality of life using International Prostate Symptom Score (IPSS) Each question is scored from 1-5, 1 being the better outcome and 5 being the worst outcome.	5 years

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Amandeep Taggar, MD, Sunnybrook

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2027

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: FIRST STAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No