SRAM Study_Postate Cancer

Phase 2

Active, not recruiting

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)

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Conventional IMRT	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	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Toxicities will be assessed by AE CTC version 4 between 2 treatment arms
To compare health-related quality of life (HRQOL) between SBRT and conventional IMRT	4 years	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	5 years

Locations (1): Department of Clinical Oncology, Prince of Wales Hospital
🇭🇰
Hong Kong, Hong Kong

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