5STAR: 5 Fractions of Pelvic SABR With Intra Prostatic SABR

Sponsor
Andrew Loblaw (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02911636
Collaborator
(none)
30
1
72

Study Details

Study Description

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
  • Radiation: Pelvic SABR with intra-prostatic SABR
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
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 :
Oct 1, 2016
Actual Primary Completion Date :
Sep 1, 2017
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Pelvic SABR with intra-prostatic SABR

Radiation: Pelvic SABR with intra-prostatic SABR
described elsewhere

Outcome Measures

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 [3 months after accrual target is reached]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Andrew Loblaw

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrew Loblaw, Principal investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02911636
Other Study ID Numbers:
  • 360-2016
First Posted:
Sep 22, 2016
Last Update Posted:
Nov 24, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2020