Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer (PROSINT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04147806
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Madhur Garg, Albert Einstein College of Medicine

Tracking Information
First Submitted Date  ICMJE October 10, 2019
First Posted Date  ICMJE November 1, 2019
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE August 1, 2016
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
Number of patients with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0 [ Time Frame: Participants should be followed continuously, for the duration of 5 years ]
Comparison of treatment related adverse events as measured by Common Toxicity Criteria for Adverse Effects v4.0 over a 5 year time frame
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04147806 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • Biochemical outcome based on Prostate Specific Antigen (PSA) assessment [ Time Frame: Participants should be followed continuously for the duration of 5 years ]
  • Quality of life assessment based on International Prostate Symptom Score (IPSS) [ Time Frame: Participants should be followed continuously for the duration of 5 years ]
    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms.The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
  • Pathological response based on biopsy at 24 months post-treatment [ Time Frame: Participants should be followed continuously for the duration of 5 years ]
  • Quality of life assessment based on International Index of Erectile Function (IIEF) [ Time Frame: Participants should be followed continuously for the duration of 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer
Official Title  ICMJE A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer
Brief Summary

The present study evaluates clinical outcomes and treatment-related toxicity following definitive ultra-high dose external beam radiotherapy delivered with two different regimens in patients with intermediate-risk adenocarcinoma of the prostate. Modern computer-driven technology enables the implementation of ultra-high hypofractionated Image-Guided Radiotherapy (IGRT) safely.

Prostate cancer patients classified according to the current National Comprehensive Cancer Network (NCCN) guidelines as intermediate risk (biopsy Gleason score of 7 and/or Prostate Specific Antigen (PSA) level >10 and ≤20 ng/mL and/or Stage T1, T2a, T2b or T2c) are eligible for this study.

Patients will undergo IGRT with volumetric intensity-modulated arc radiotherapy (VMAT) with state-of-the-art treatment-planning and quality assurance procedures. Emphasis is placed on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility. A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility, while a urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking. Previously untreated patients with intermediate-risk prostate cancer will be prospectively randomized to receive either 45 Gy in five fractions of 9 Gy each vs. 24 Gy in a single-dose.

Patients will be followed at one month post-treatment and every 3 months for up to 12 months (+/- 4 weeks) and every 6 months thereafter. Acute and chronic toxicity evaluations will focus on urinary, rectal and sexual functions and will be assessed through validated questionnaires. Serum PSA values will be regularly acquired during follow-up. A multiparametric MRI will be performed at baseline, 6, 12 and 24 months following intervention. Additionally, a post-treatment diffusion-weighted MRI (DW-MRI) will be performed within 15 minutes of the first treatment, to measure early physiologic changes, such as perfusion and ischemia, that may correlate with clinically relevant end-points. Post-treatment prostate needle biopsies will be obtained at 24 months to evaluate pathologic response to therapy. The study will be continuously monitored for a minimum of 5 years. In the event unexpected severe (grade ≥3) toxicities are observed in any one of the treatment arms, the study will be terminated according to the stopping rule >3/first 15 patients.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Radiation: IGRT 45 Gy in 5 fractions of 9 Gy
    Administration of 9 Gy in five consecutive days, to a total dose of 45 Gy radiation
  • Radiation: IGRT 24 Gy single dose
    Administration of a single dose of 24 Gy in one session
  • Drug: Dexamethasone
    4 mg by mouth on treatment days only
  • Drug: Tamsulosin
    0.4 mg by mouth daily starting the day of simulation and until 2 weeks post-treatment.
Study Arms  ICMJE
  • Active Comparator: IGRT 45 Gy in 5 fractions of 9 Gy
    Hypofractionated IGRT at a prescription dose of 45 Gy in 5 fractions of 9 Gy delivered in five consecutive days
    Interventions:
    • Radiation: IGRT 45 Gy in 5 fractions of 9 Gy
    • Radiation: IGRT 24 Gy single dose
    • Drug: Dexamethasone
    • Drug: Tamsulosin
  • Experimental: IGRT 24 Gy single dose
    single fraction IGRT at a prescription dose of 24 Gy
    Interventions:
    • Radiation: IGRT 45 Gy in 5 fractions of 9 Gy
    • Radiation: IGRT 24 Gy single dose
    • Drug: Dexamethasone
    • Drug: Tamsulosin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2022
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed study specific informed consent form;
  • Histologic confirmation of adenocarcinoma of the prostate by biopsy;
  • PSA ≤ 20 ng/mL;
  • Gleason score 7;
  • Staging MRI must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c;
  • No direct evidence of regional or distant metastases after appropriate staging studies;
  • Age ≥ 50;
  • Performance Status 0-2;
  • Internation Prostate Symptom Score score must be ≤ 15 (alpha blockers allowed);
  • CT scan or Ultrasound-based volume estimation of prostate gland ≤ 100 grams;

Exclusion Criteria:

  • Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies
  • Prior invasive malignancy unless disease-free for a minimum of 5 years
  • Tumour Clinical stage T3 or T4 on MRI
  • PSA > 20 ng/mL
  • Gleason score > 7
  • Previous pelvic radiotherapy
  • Previous surgery for prostate cancer
  • Previous transurethral resection of the prostate (TURP)
  • History of Crohn's Disease or Ulcerative Colitis
  • Previous significant urinary obstructive symptoms
  • Significant psychiatric illness
  • Ultrasound or CT estimate of prostate volume > 100 grams
  • Severe, active co-morbidity
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah Yukelis 718-920-5636 syukelis@montefiore.org
Contact: Hilda Haynes-Lewis 718-920-8819 hhaynes@montefiore.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04147806
Other Study ID Numbers  ICMJE 2016-6545
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Madhur Garg, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Madhur Garg, MD Associate Clinical Director
PRS Account Albert Einstein College of Medicine
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP