5 Fractions of Pelvic SABR With Intra Prostatic SABR

Prostate Cancer Clinical Trial

— 5STAR  

Official title:

5 Fractions of Pelvic SABR With Intra Prostatic SABR

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02911636
• Other study ID #: 360-2016
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: October 2022

Study information

• Verified date: November 2020
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2022
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Pelvic SABR with intra-prostatic SABR
described elsewhere

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Andrew Loblaw

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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