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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236752
Recruitment Status : Active, not recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
Prostate Cancer Canada
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
HIGH RISK PROSTATE CANCER Radiation: Stereotactic Ablative Body Radiation (SBRT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Pelvic Brachytherapy With HDR Boost for Dose Escalation in High Tier Intermediate and High Risk Prostate Cancer (SPARE)
Actual Study Start Date : September 29, 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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)



Primary Outcome Measures :
  1. Acute GI and GU toxicities [ Time Frame: Baseline (start of treatment) to 6 weeks post completion of Radiation treatment ]
    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).


Secondary Outcome Measures :
  1. Late GI and GU RTOG toxicities [ Time Frame: 6 months post start of treatment to end of 5 year follow up post completion of treatment ]
    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).

  2. Quality of Life outcome- EPIC [ Time Frame: Baseline ( start of treatment) to end of 5 year follow up post completion of treatment ]
    Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.

  3. Biochemical disease-free survival [ Time Frame: Baseline ( start of treatment) to end of 5 year follow up post completion of treatment ]
    Biochemical disease-free survival post treatment

  4. Quality of Life outcome- EQ5D [ Time Frame: Baseline to end of 5 year follow up post completion of treatment ]
    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.)


Other Outcome Measures:
  1. Quality of Life outcome- PORPUS-U [ Time Frame: Baseline ( start of treatment) to end of 5 year follow up post completion of treatment ]
    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.)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04236752


Locations
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Canada, Ontairo
Sunnybrook Health Sciences Center
Toronto, Ontairo, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Prostate Cancer Canada

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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04236752    
Other Study ID Numbers: SPARE
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Overall study data will be available thru publications. Individual Participants Data will not be made public.

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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
Genital Diseases, Male
Prostatic Diseases