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Prostate Boost Irradiation With Stereotactic Body RT (SBRT) (PBS)

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ClinicalTrials.gov Identifier: NCT03380806
Recruitment Status : Not yet recruiting
First Posted : December 21, 2017
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Naghmeh Isfahanian, Juravinski Cancer Center

Brief Summary:
A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio. Prostate radiotherapy boost will be administered after standard pelvic radiotherapy. Subjects will be followed for 24 months post radiation treatment for Quality of Life assessment and toxicity.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: LHRH agonist Radiation: Pelvic Radiation Radiation: Stereotactic Body Radiotherapy (SBRT) Radiation: Conventional Radiotherapy (CRT) Prostate Boost Phase 2

Detailed Description:
In this study we investigate stereotactic body radiotherapy (SBRT) as a boost radiotherapy treatment, following pelvic radiotherapy, in patients with high risk prostate cancer (PrCa) treated with Androgen Deprivation Therapy (ADT). One hundred patients with localized high risk PrCa will receive ADT for a total of 3 years. Three months after initiation of ADT all patients will receive pelvic (lymph node and prostate) treatment of 45Gy in 25 fractions (5 days per week). Then patients will be randomized to receive either The conventional radiotherapy (CRT) of 33 - 35 Gy in 16 fractions (5 days per week - over 22 days) (comparator arm) or SBRT boost treatment of 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days) (experimental arm). SBRT boost treatment will be delivered with either cyberknife or VMAT technique.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial Investigating Stereotactic Body RadioTherapy (SBRT) for Prostate Boost Irradiation in the Treatment of High Risk Prostate Cancer (PrCa)
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm 1
Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist
Drug: LHRH agonist
Standard LHRH agonist for 3 years
Other Name: Eligard
Radiation: Pelvic Radiation
Pelvic Radiation
Radiation: Conventional Radiotherapy (CRT) Prostate Boost
CRT: 33 - 35 Gy in 16 fractions (5 days per week - over 22 days)
Experimental: Arm 2
Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist
Drug: LHRH agonist
Standard LHRH agonist for 3 years
Other Name: Eligard
Radiation: Pelvic Radiation
Pelvic Radiation
Radiation: Stereotactic Body Radiotherapy (SBRT)
SBRT: 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days)



Primary Outcome Measures :
  1. Short Term Quality of Life (QoL) [ Time Frame: up to 6 months post radiation ]
    To compare early QoL (up to 6 months post RT) in patients with high risk adenocarcinoma of the prostate treated with ADT and RT in the form of pelvic nodal irradiation and prostate boost with standard fractionation, or pelvic nodal irradiation and prostate boost with SBRT using Cyberknife or VMAT. QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals after completion of radiotherapy using the established Prostate QoL (The Expanded Prostate cancer Index Composite (EPIC-26 instrument)). Higher EPIC score represent a better outcome


Secondary Outcome Measures :
  1. Long Term Quality of Life (QoL) [ Time Frame: 24 months ]
    long term QoL QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals up to 24 months month after completion of radiotherapy using the established Prostate QoL (The Expanded Prostate cancer Index Composite (EPIC-26 instrument)). Higher EPIC score represent a better outcome

  2. Urinary function assessment [ Time Frame: 24 months ]

    short and long term quality of urinary function (The International Prostate Symptom Score (IPSS)).

    Total IPSS is between 1-35 / lower score shows better function.


  3. Late Toxicity [ Time Frame: 12-24 months ]
    Grade 2-4 treatment related late (12-24 months), bladder and bowel related toxicity evaluated by the Expanded Common Toxicity Criteria of the National Cancer Institute of Canada (NCI)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological and or clinical diagnosis of high risk adenocarcinoma of the prostate within six months of entry (stage T3 or higher and/or Gleason score 8 or higher and/or initial PSA level above 20;)
  • No radiographic evidence of metastatic disease to the abdomen, lymph nodes, bone or other distant organs; determined by standard staging investigations (bone scan and CT-scan of the abdomen and pelvis) or incidental findings (localized N0, M0 disease)
  • Patient is able to complete the quality of life questionnaires in English.
  • Informed consent obtained

Exclusion Criteria:

  • • Histological diagnosis of carcinoma of the prostate more than six months prior to potential registration date;
  • Previous treatment for carcinoma of the prostate (other than biopsy or TURP), including bilateral orchiectomy;
  • Patients previously on more than twelve weeks of hormone therapy for their PrCa;
  • Past history of other malignancies except: adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for more than 3 years;
  • Contraindications to placement of gold seeds for daily prostate localization;
  • Previous pelvic RT and/or significant pelvic surgery;
  • Severe diverticular or inflammatory bowel disease (as determined by the treated radiation oncologist)
  • Previous hip replacement
  • PSA over 50
  • IPSS 20 or higher
  • TRUS-based prostate
  • volume of > 80 cc

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): NCT03380806


Contacts
Contact: Theos Tsakiridis, Senior Principle Investigator, MD, FRCPC 905-387-9495 theos.tsakiridis@hhsc.ca
Contact: Naghmeh Isfahanian, Junior Principle Investigator, MD, FRCPC 905-387-9495 isfahanian@hhsc.ca

Locations
Canada, Ontario
Juravinski Cancer Centre Not yet recruiting
Hamilton, Ontario, Canada
Principal Investigator: Theodorous Tsakiridis, MD, FRPC         
Principal Investigator: Naghmeh Isfahanian, MD, FRCPC         
Sponsors and Collaborators
Juravinski Cancer Center
Sanofi

Responsible Party: Naghmeh Isfahanian, Term Professional staff, Juravinski Cancer Center
ClinicalTrials.gov Identifier: NCT03380806     History of Changes
Other Study ID Numbers: 4178
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Naghmeh Isfahanian, Juravinski Cancer Center:
stereotactic body radiotherapy (SBRT)
conventional radiotherapy (CRT)
High risk prostate cancer
quality of life (QoL)
The Expanded Prostate cancer Index Composite (EPIC-26)
International Prostate Symptom Score (IPSS)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases