Clinical Trials/NCT03938649

NCT03938649

Active, not recruiting

Phase 2

Randomized Phase II Study of Combination Androgen Deprivation Therapy (ADT) and Radiotherapy in High Risk Prostate Cancer: Stereotactic Body Radiotherapy vs conventionAl IMRT to Prostate and Pelvic Nodes (SRAM Study)

CCTU1 site in 1 country120 target enrollmentMay 15, 2019

ConditionsAdvanced Prostate Cancer

InterventionsConventional IMRT SBRT

DrugsSBRT

Overview

Phase: Phase 2
Intervention: Conventional IMRT
Conditions: Advanced Prostate Cancer
Sponsor: CCTU
Enrollment: 120
Locations: 1
Primary Endpoint: To compare acute toxicities between SBRT and conventional IMRT
Status: Active, not recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 2 randomized study for High risk localized prostate cancer (T3 to T4 disease and/or PSA > 20 and/or Gleason score ≥ 8) without evidence of distant and nodal metastasis.

Patient will be randomized to:Arm 1

Conventional IMRT RapidArc IMRT to prostate and pelvic nodes. 76Gy to prostate, 70Gy to proximal 2/3 of seminal vesicles, and 50Gy to pelvic nodes (up to bifurcation of common iliac nodes).
38 fractions of daily treatment, Monday to Friday

or Arm 2

SBRT

RapidArc IMRT to prostate and pelvic nodes. 40Gy to prostate, 36.25Gy to proximal 2/3 of seminal vesicles, and 25Gy to pelvic nodes (up to bifurcation of common iliac nodes)
5 fractions of weekly treatment. Once fraction per week. All patients will be given neoadjuvant and adjuvant androgen deprivation therapy (detail as below)

Registry

clinicaltrials.gov

Start Date

May 15, 2019

End Date

December 31, 2028

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

CCTU

Responsible Party

Sponsor Investigator

Principal Investigator

CCTU

Comprehensive Clinical Trial Unit

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

•Histological confirmation of prostate adenocarcinoma
•High risk prostate cancer patients (i.e. T3 to T4 disease and/or PSA \> 20 and/or Gleason score ≥ 8)
•ECOG performance score 0-1
•History/physical examination within 2 weeks prior to registration
•Able to sign informed-consent

Exclusion Criteria

•Patients with active cancer other than prostate cancer and non-melanoma skin cancer.
•Evidence of distant metastases
•Regional lymph node involvement
•Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
•Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
•Previous hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g. DES), or surgical castration (orchiectomy)
•Unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
•Patients who have received prior chemotherapy.

Arms & Interventions

Conventional IMRT

* RapidArc IMRT to prostate and pelvic nodes. 76Gy to prostate, 70Gy to proximal 2/3 of seminal vesicles, and 50Gy to pelvic nodes (up to bifurcation of common iliac nodes). * 38 fractions of daily treatment, Monday to Friday

Intervention: Conventional IMRT

SBRT

* RapidArc IMRT to prostate and pelvic nodes. 40Gy to prostate, 36.25Gy to proximal 2/3 of seminal vesicles, and 25Gy to pelvic nodes (up to bifurcation of common iliac nodes) * 5 fractions of weekly treatment. Once fraction per week.

Intervention: SBRT

Outcomes

Primary Outcomes

To compare acute toxicities between SBRT and conventional IMRT

Time Frame: 4 years

Toxicities will be assessed by AE CTC version 4 between 2 treatment arms

Secondary Outcomes

To compare the progression-free survival at 5 years(5 years)
To compare the overall survival at 5 years(5 years)
To compare the late toxicities between 2 treatment arms(5 years)
To compare health-related quality of life (HRQOL) between SBRT and conventional IMRT(4 years)
To compare the biochemical-failure free survival at 5 years(5 years)