Stereotactic Pelvic Brachytherapy With HDR Boost for Dose Escalation in High Tier Intermediate and High Risk Prostate ca (SPARE)

Stereotactic Pelvic Brachytherapy With HDR Boost for Dose Escalation in High Tier Intermediate and High Risk Prostate Cancer (SPARE)

HDR brachytherapy in conjunction with pelvic SABR in high tier intermediate and high risk prostate cancer patients can provide a safe and effective means of radiotherapy dose escalation.

Utilizing multiparametric MRI to focally boost the dominant intraprostatic lesion during HDR brachytherapy is safe and feasible.

Study Overview

• Status: Unknown
• Conditions: HIGH RISK PROSTATE CANCER
• Intervention / Treatment: Radiation: Stereotactic Ablative Body Radiation (SBRT)

Detailed Description

HDR brachytherapy:

Under general anesthetic, prostate will be implanted transperineally using up to 18 catheters. Three gold seed fudicials will also be implanted transperineally at base, midgland and apex forSABR treatment. Prostate will be contoured as Clinical Target Volume (CTV) on the transrectal ultrasound (TRUS) based ONCENTRA planning system. Rectum and urethra will be contoured as organs at risk. 15Gy will be prescribed to CTV as the MPD (minimal Peripheral Dose).

Treatment Delivery-SABR There will be a 2 week interval between HDR and SABR component to allow for normal tissue recovery and radiotherapy planning time. Daily image guidance will be performed using the implanted fiducials to calculate patient shifts to ensure proper positioning. Post-treatment images will be taken to estimate intrafraction motion.

Androgen Deprivation Therapy Twelve to 18 months of luteinizing-hormone releasing hormone agonists (LHRHa) will be used. Anti-androgen and neoadjuvant LHRHa can be used according to physician discretion

Follow-Up and Toxicity Assessment Time zero will be the start of radiotherapy. Baseline rectal and urinary function will be recorded using common toxicity criteria adverse effect (CTCAE v3.0) and Expanded prostate Cancer Index Composite (EPIC). CTCAE v3.0 and EPIC assessments will be done at weeks 3, 5 and 12 weeks. Bloodwork (PSA and testosterone), quality of life (EPIC) and late GI and GU toxicity evaluation (using the RTOG/EORTC Late Radiation Morbidity Scheme) will be performed every 6 months for the first 5 years.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontairo
    • Toronto, Ontairo, Canada, M4N 3M5
      • Sunnybrook Health Sciences Center

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:

• Informed consent obtained
• Men >18 years
• Histologically confirmed prostate adenocarcinoma (centrally reviewed)
• High tier intermediate risk defined as :

Clinical stage T1-T2c AND PSA 10-20ng/ml AND {PSA>10ng/ml AND (T2b-2c Or Gleason 7)} OR Gleason 4+3

-High-risk prostate cancer, defined as at least one of: Clinical stage T3, OR Gl 8-10, OR PSA > 20 ng/mL

Inclusion Criteria:

• Prior pelvic radiotherapy
• Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
• Diagnosis of bleeding diathesis
• Large prostate (>50cm3) on imaging
• No evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7 nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
• Definitive regional or distant metastatic disease on staging investigations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Single arm radiotherapy; HDR Brachytherapy Boost of 15Gy to the prostate followed by Stereotactic Ablative Body Radiation (SBRT) 25 Gy in 5 fractions, once weekly to prostate, SVs and pelvic lymph nodes + 6-18 months of ADT	Radiation: Stereotactic Ablative Body Radiation (SBRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute GI and GU toxicities	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v3.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks. This will be calculated using the F distribution method (exact confidence limits).	Baseline (start of treatment) to 6 weeks post completion of Radiation treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late GI and GU RTOG toxicities	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v3.0, Change From 6 months post treatment to end of 5 year follow up. This will be calculated using the F distribution method (exact confidence limits).	6 months post start of treatment to end of 5 year follow up post completion of treatment
Quality of Life outcome- EPIC	Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.	Baseline ( start of treatment) to end of 5 year follow up post completion of treatment
Biochemical disease-free survival	Biochemical disease-free survival post treatment	Baseline ( start of treatment) to end of 5 year follow up post completion of treatment
Quality of Life outcome- EQ5D	Assess the impact of modifiable life style factors on radiation toxicity as well as Determine the health preference values using the EQ5D(EQ-5D is the name of the instrument and is not an acronym.)	Baseline to end of 5 year follow up post completion of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life outcome- PORPUS-U	Assess the impact of modifiable life style factors on radiation toxicity as well as Determine the health preference values using the PORPUS -U(PORPUS-U is the name of the instrument and is not an acronym.)	Baseline ( start of treatment) to end of 5 year follow up post completion of treatment

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Prostate Cancer Canada

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2014
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

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: SPARE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Overall study data will be available thru publications. Individual Participants Data will not be made public.

Drug and device information, study documents

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