SRAM study_Postate Cancer

Advanced Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03938649
• Other study ID #: PST008
• Status: Recruiting
• Phase: Phase 2
• Start date: May 15, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Chinese University of Hong Kong
• Contact: Darren MC POON, FHKCR
• Phone: 3505 2128
• Email: mc_poon[@]clo.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Advanced Prostate Cancer
• Prostatic Neoplasms

Intervention

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. All patients will be given neoadjuvant and adjuvant androgen deprivation therapy.

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. All patients will be given neoadjuvant and adjuvant androgen deprivation therapy.

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
CCTU

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	4 years
Secondary	To compare the biochemical-failure free survival at 5 years		5 years
Secondary	To compare the progression-free survival at 5 years		5 years
Secondary	To compare the overall survival at 5 years		5 years
Secondary	To compare the late toxicities between 2 treatment arms	Toxicities will be assessed by AE CTC version 4 between 2 treatment arms	5 years