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Clinical Trials/NCT03938649
NCT03938649Active, not recruitingPhase 2

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)

CCTU1 site in 1 country120 target enrollmentStarted: May 15, 2019Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Sponsor
CCTU
Enrollment
120
Locations
1
Primary Endpoint
To compare acute toxicities between SBRT and conventional IMRT
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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
  • •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.

Arms & Interventions

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

Intervention: Conventional IMRT (Radiation)

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.

Intervention: SBRT (Drug)

Outcomes

Primary Outcomes

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

  • 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)
  • To compare health-related quality of life (HRQOL) between SBRT and conventional IMRT(4 years)
  • To compare the biochemical-failure free survival at 5 years(5 years)

Investigators

Sponsor
CCTU
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

CCTU

Comprehensive Clinical Trial Unit

Chinese University of Hong Kong

Study Sites (1)

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