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SRAM study_Postate Cancer

Sponsor
CCTU (Other)
Overall Status
Recruiting
CT.gov ID
NCT03938649
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
67.6
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 15, 2019
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 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 [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 [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 [5 years]

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

  4. To compare the overall survival at 5 years [5 years]

  5. To compare the late toxicities between 2 treatment arms [5 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

  • 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

Locations

Site City State Country Postal Code
1 Department of Clinical Oncology, Prince of Wales Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • CCTU

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT03938649
Other Study ID Numbers:
  • PST008
First Posted:
May 6, 2019
Last Update Posted:
Jul 28, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Jul 28, 2021