5 Fractions of Pelvic SABR With Intra Prostatic SABR

NCT02911636 | Unknown

• 1 other identifier: 360-2016
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (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

Study Arms (1)

Arm 1

EXPERIMENTAL

Pelvic SABR with intra-prostatic SABR

Radiation: Pelvic SABR with intra-prostatic SABR

Interventions

Pelvic SABR with intra-prostatic SABR RADIATION

described elsewhere

Arm 1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrew Loblaw: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 22, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2022
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share