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2 Ablative RadioTherapy Treatments for Prostate Cancer (EARTH)

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ClinicalTrials.gov Identifier: NCT04654338
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew Loblaw, Sunnybrook Health Sciences Centre

Brief Summary:
Favorable-risk prostate cancer represent a large proportion of patients diagnosed with prostate cancer and image guided radiation therapy (IGRT) is commonly used to treat these patients using protracted courses of up to 39 treatments over 8 weeks. Stereotactic ablative body radiotherapy (SABR) protocols hold the promise of more convenience, less side effects, less cost and improved system capacity without sacrificing excellent cancer control rates. By the same token, prostate high-dose rate (HDR) brachytherapy boost has been shown to be superior to standard external beam radiation. While two HDR fractions appear to optimize patient convenience and outcomes while minimizing costs, we wanted to determine the tolerability of combining one MR-guided HDR treatment with one SABR treatment to further reduce HDR resource use while maintaining favourable treatment outcomes.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: SABR + HDR Phase 2 Phase 3

Detailed Description:

Pre-Treatment:

Planning CT and mpMRI imaging for SABR TRUS with biopsy and insertion of Gold Seed Fiducial Markers Biobanking of urine, blood and biopsy tissue (as per REB#079-2006 Odette Cancer Centre (OCC) biobanking protocol)

Stereotactic Ablative Body Radiation (SABR):

13.5Gy x 1 to whole prostate + 1cm seminal vesicles 2 weeks post-planning, treatment will be delivered as per standard treatment protocols on SABR-compatible linear accelerator with a six-degree of freedom couch. Cone-beam CT imaging will be performed using the implanted fiducials to set up each treatment. All dosimetric parameters will be recorded.

Inter-treatment (approx 1 week post-SABR):

Planning mpMRI and TRUS imaging for HDR Biobanking of urine and blood (as per REB#079-2006 OCC biobanking protocol)

HDR brachytherapy:

13.5 Gy x 1 to the prostate, <20 Gy to DIL Approx 2-3 weeks post-SABR, the HDR dose prescription of 13.5 Gy to the whole gland and <20 Gy to MRI visible lesion will be delivered in one fraction, assuming that dose constraints to critical organs can be met. All dosimetric parameters will be recorded

Patient Assessments / Follow-up Time zero will be the date of SABR treatment. Baseline rectal, urinary and sexual function will be recorded prior to treatment. Acute toxicities will be assessed at 6, 12 and 24 weeks and late toxicities will be assessed at month 9, 24 and every 6 months until year 5 using the Common Terminology Criteria Adverse Events, V 4.0. Bloodwork (PSA and testosterone) and International Prostate Symptom Score (IPSS) evaluations will be performed at baseline week 6, month 3, 6, 9 and 24, and every 6 months until year 5. QOL using the Expanded Prostate Cancer Index Composite (EPIC), EQ-5D and PORPUS questionnaires will be obtained at baseline, month 3, 6, 9 and 24 and every 6 months until year 5. Post-treatment biobanking will be done at 13 and 52 weeks (as per REB#079-2006 OCC biobanking protocol)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : January 29, 2022
Estimated Study Completion Date : July 29, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Intervention Arm Radiation: SABR + HDR
One SABR treatment + one HDR brachytherapy treatment




Primary Outcome Measures :
  1. Acute Toxicities [ Time Frame: 6 months ]
    Acute GU and GI toxicities according to the NCI CTCAE v4.0


Secondary Outcome Measures :
  1. Late Toxicities [ Time Frame: 5 years ]
    Late GU and GI toxicities according to the NCI CTCAE v4.0

  2. QOL [ Time Frame: 5 years ]
    Quality of life changes utilizing the Expanded Prostate Index Composite (EPIC)

  3. PSA [ Time Frame: 5 years ]
    Biochemical failure and PSA kinetics using PSA response rate



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate
  • Favorable risk disease defined as either:

    • Low risk disease: T1-T2c, grade group 1, PSA < 10 ng/ml or
    • Favorable intermediate risk disease: One of T2c, grade group 2, or PSA 10-20 ng/ml. Patients cannot have percent core positivity > 50%
  • Prostate volume < 60 cc as determined by US, CT or MRI
  • Ability to undergo MR imaging
  • Provide written informed consent

Exclusion Criteria:

  • Documented nodal or distant metastases
  • Previous pelvic radiotherapy
  • Previous transurethral resection of prostate, previous prostatectomy or HIFU
  • Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
  • Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >15
  • Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
  • Significant medical co-morbidity rendering patient unsuitable for general anaesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04654338


Contacts
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Contact: Merrylee McGuffin, MSc 416-480-6100 ext 85454 Merrylee.Mcguffin@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Andrew Loblaw, MD, FRCPC    416-480-4806    Andrew.Loblaw@sunnybrook.ca   
Contact: Merrylee McGuffin, MSc, MRT(T)    416-480-6100 ext 85454    Merrylee.Mcguffin@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Andrew Loblaw, MD Sunnybrook Health Sciences Centre
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Responsible Party: Andrew Loblaw, GU Radiation Oncology Site Group Lead, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04654338    
Other Study ID Numbers: 3592
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases