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Active, Not Recruiting

NCT Number: NCT03938649

SRAM study_Postate Cancer

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional IMRT

Radiation

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.

SBRT

Drug

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 outcomes

  1. 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

Secondary outcomes

  1. To compare health-related quality of life (HRQOL) between SBRT and conventional IMRT

    Time frame: 4 years

    Questionnaire EPIC will be used at pre-treatment, during treatment and at 3, 6, 9, 12, 18 and 24 months post treatment

  2. To compare the biochemical-failure free survival at 5 years

    Time frame: 5 years

  3. To compare the progression-free survival at 5 years

    Time frame: 5 years

  4. To compare the overall survival at 5 years

    Time frame: 5 years

  5. To compare the late toxicities between 2 treatment arms

    Time frame: 5 years

    Toxicities will be assessed by AE CTC version 4 between 2 treatment arms

Sponsors and collaborators

Lead sponsor

CCTU

Other

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
May 6, 2019
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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