Advanced Prostate CancerPhase 2NCT03938649
SRAM study_Postate Cancer
A Phase 2 study testing Conventional IMRT and SBRT in people with Advanced Prostate Cancer, run by CCTU at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Cancer
- What is being tested?
- Conventional IMRT and SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 May 2019to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
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)
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
Read more
- 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)
- Conditions
- Advanced Prostate Cancer
- Being tested
- Conventional IMRT, SBRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional IMRTRadiation
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.
SBRTDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Conventional IMRT |
| 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. Receives: Drug: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare acute toxicities between SBRT and conventional IMRT
Toxicities will be assessed by AE CTC version 4 between 2 treatment arms
Measured: 4 years
Secondary outcomes (5)
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
Measured: 4 years
To compare the biochemical-failure free survival at 5 years
Measured: 5 years
To compare the progression-free survival at 5 years
Measured: 5 years
To compare the overall survival at 5 years
Measured: 5 years
To compare the late toxicities between 2 treatment arms
Toxicities will be assessed by AE CTC version 4 between 2 treatment arms
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start15 May 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCTU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CCTU, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938649
- Sponsor's protocol ID
- PST008
- Status last verified
- Mar 2026
- First submitted
- 18 Apr 2019
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03938649
- Acronym / sponsor ID
- PST008
- Conditions
- Advanced Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CCTUUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional IMRT | Experimental | 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 |
| SBRT | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional IMRTRapidArc 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. | Radiation | Conventional IMRT |
| SBRTRapidArc 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. | Drug | SBRT |
Primary outcome
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
5 secondary outcomes
To compare health-related quality of life (HRQOL) between SBRT and conventional IMRT
Time frame: 4 years
To compare the biochemical-failure free survival at 5 years
Time frame: 5 years
To compare the progression-free survival at 5 years
Time frame: 5 years
To compare the overall survival at 5 years
Time frame: 5 years
To compare the late toxicities between 2 treatment arms
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conventional IMRT and SBRT in people with Advanced Prostate Cancer, run by CCTU at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare acute toxicities between SBRT and conventional IMRT (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.