SRAM study_Postate Cancer

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)

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)

Study Overview

• Status: Recruiting
• Conditions: Advanced Prostate Cancer
• Intervention / Treatment: Radiation: Conventional IMRT; Drug: SBRT

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jane KOH, RN; Phone Number: 3505 1142; Email: jane@clo.cuhk.edu.hk
• Study Contact Backup: Name: Darren MC POON, FHKCR; Phone Number: 3505 2128; Email: mc_poon@clo.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Department of Clinical Oncology, Prince of Wales Hospital
    • Contact: Darren MC POON, FHKCR; Phone Number: 35052128; Email: mc_poon@clo.cuhk.edu.hk
    • Contact: Jane KOH, RN; Phone Number: 35051142; Email: jane@clo.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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
• Age ≥ 18
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Radiation: 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. All patients will be given neoadjuvant and adjuvant androgen deprivation therapy.
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare acute toxicities between SBRT and conventional IMRT	Toxicities will be assessed by AE CTC version 4 between 2 treatment arms	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare health-related quality of life (HRQOL) between SBRT and conventional IMRT	Questionnaire EPIC will be used at pre-treatment, during treatment and at 3, 6, 9, 12, 18 and 24 months post treatment	4 years
To compare the biochemical-failure free survival at 5 years		5 years
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	Toxicities will be assessed by AE CTC version 4 between 2 treatment arms	5 years

Collaborators and Investigators

• Sponsor: CCTU

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PST008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No