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)
1 other identifier
interventional
120
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2019
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedStudy Start
First participant enrolled
May 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
March 4, 2026
March 1, 2026
8.6 years
April 18, 2019
March 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
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
Study Arms (2)
Conventional IMRT
EXPERIMENTAL* 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
SBRT
EXPERIMENTAL* 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CCTUlead
Study Sites (1)
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Comprehensive Clinical Trial Unit
Study Record Dates
First Submitted
April 18, 2019
First Posted
May 6, 2019
Study Start
May 15, 2019
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share