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SRAM study_Postate Cancer

Primary Purpose

Advanced Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Conventional IMRT
SBRT
Sponsored by
CCTU
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Clinical Oncology, Prince of Wales HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional IMRT

SBRT

Arm Description

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

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.

Outcomes

Primary Outcome Measures

To compare acute toxicities between SBRT and conventional IMRT
Toxicities will be assessed by AE CTC version 4 between 2 treatment arms

Secondary Outcome Measures

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
To compare the biochemical-failure free survival at 5 years
To compare the progression-free survival at 5 years
To compare the overall survival at 5 years
To compare the late toxicities between 2 treatment arms
Toxicities will be assessed by AE CTC version 4 between 2 treatment arms

Full Information

First Posted
April 18, 2019
Last Updated
September 13, 2022
Sponsor
CCTU
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1. Study Identification

Unique Protocol Identification Number
NCT03938649
Brief Title
SRAM study_Postate Cancer
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CCTU

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional IMRT
Arm Type
Experimental
Arm Description
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
Arm Title
SBRT
Arm Type
Experimental
Arm Description
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 Type
Radiation
Intervention Name(s)
Conventional IMRT
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
SBRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare acute toxicities between SBRT and conventional IMRT
Description
Toxicities will be assessed by AE CTC version 4 between 2 treatment arms
Time Frame
4 years
Secondary Outcome Measure Information:
Title
To compare health-related quality of life (HRQOL) between SBRT and conventional IMRT
Description
Questionnaire EPIC will be used at pre-treatment, during treatment and at 3, 6, 9, 12, 18 and 24 months post treatment
Time Frame
4 years
Title
To compare the biochemical-failure free survival at 5 years
Time Frame
5 years
Title
To compare the progression-free survival at 5 years
Time Frame
5 years
Title
To compare the overall survival at 5 years
Time Frame
5 years
Title
To compare the late toxicities between 2 treatment arms
Description
Toxicities will be assessed by AE CTC version 4 between 2 treatment arms
Time Frame
5 years

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darren MC POON, FHKCR
Phone
3505 2128
Email
mc_poon@clo.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Jane KOH, RN
Phone
3505 1142
Email
jane@clo.cuhk.edu.hk
Facility Information:
Facility Name
Department of Clinical Oncology, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darren MC POON, FHKCR
Phone
35052128
Email
mc_poon@clo.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Jane Koh, RN
Phone
35051142
Email
jane@clo.cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No

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