NCT03938649Active, not recruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 18 Apr 2019
- Start date
- 15 May 2019
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- CCTU
- Diseases
- Prostate cancer
- NCT number
- NCT03938649
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 15 May 2019 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Patients who have received prior chemotherapy.
Other illness
- Patients with active cancer other than prostate cancer and non-melanoma skin cancer.
- 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
Other
- Evidence of distant metastases
- Regional lymph node involvement
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Clinical Oncology, Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.