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SRAM study_Postate Cancer

  • Clinicaltrials.gov identifier

    NCT03938649

  • Recruitment Status

    Recruiting

  • First Posted

    May 6, 2019

  • Last update posted

    June 22, 2020

Study Description

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)

  • Condition or Disease:Advanced Prostate Cancer
  • Intervention/Treatment: Radiation: Conventional IMRT
    Drug: SBRT
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 120 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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)
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: December 2023
  • Estimated Study Completion Date: December 2024

Arms and interventions

Arm Intervention/treatment
Experimental: 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
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.
Experimental: 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.
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.

Outcome Measures

  • Primary Outcome Measures: 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 Outcome Measures: 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

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Darren MC POON, FHKCR 3505 2128 mc_poon@clo.cuhk.edu.hk

Contact: Jane KOH, RN 3505 1142 jane@clo.cuhk.edu.hk

Locations

Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong

Sponsors and Collaborators

CCTU

More Information

  • Responsible Party: CCTU
  • ClinicalTrials.gov Identifier: NCT03938649 History of Changes
  • Other Study ID Numbers: PST008
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: June 22, 2020
  • Last Verified: June 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Prostatic Neoplasms