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5 Fractions of Pelvic SABR With Intra Prostatic SABR (5Star)

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: NCT02911636
Recruitment Status : Active, not recruiting
First Posted : September 22, 2016
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Loblaw, Sunnybrook Health Sciences Centre

Brief Summary:
Stereotactic Ablative Radiation(SABR) 35 Gy in 5 fractions, once weekly to prostate with simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5 fractions, once weekly simultaneously to seminal vesicles (SV's) and pelvic lymph nodes + 6-18 months of ADT

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Pelvic SABR with intra-prostatic SABR Not Applicable

Detailed Description:
SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 5 Fractions of Pelvic SABR With Intra Prostatic SABR
Actual Study Start Date : October 2016
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
Pelvic SABR with intra-prostatic SABR
Radiation: Pelvic SABR with intra-prostatic SABR
described elsewhere




Primary Outcome Measures :
  1. To document the number of patients with grade 3 or higher acute urinary and/or bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria [ Time Frame: 3 months after accrual target is reached ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma (centrally reviewed)
  • High- tier intermediate risk defined as:

PSA 10-20ng/ml AND (T2b-2c OR Gleason 7 )

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

  • Willing to give informed consent to participate in this clinical trial
  • Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire

Exclusion Criteria:

  • Prior pelvic radiotherapy
  • Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
  • Contraindication to prostate MRI
  • Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
  • Diagnosis of bleeding diathesis
  • Large prostate with significant arch interference on TRUS after 3 months of neoadjuvant ADT.
  • Previous TURP
  • Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20
  • Significant medical co-morbidity rendering patient unsuitable for general anesthetic
  • No 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.

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Responsible Party: Andrew Loblaw, Principal investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02911636     History of Changes
Other Study ID Numbers: 5Star
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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