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

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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

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: IGRT 45 Gy in 5 fractions of 9 Gy Radiation: IGRT 24 Gy single dose Drug: Dexamethasone Drug: Tamsulosin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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
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.

Experimental: IGRT 24 Gy single dose
single fraction IGRT at a prescription dose of 24 Gy
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Biochemical outcome based on Prostate Specific Antigen (PSA) assessment [ Time Frame: Participants should be followed continuously for the duration of 5 years ]
  2. 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.

  3. Pathological response based on biopsy at 24 months post-treatment [ Time Frame: Participants should be followed continuously for the duration of 5 years ]
  4. 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 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147806


Contacts
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Contact: Sarah Yukelis 718-920-5636 syukelis@montefiore.org
Contact: Hilda Haynes-Lewis 718-920-8819 hhaynes@montefiore.org

Locations
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United States, New York
Montefiore Medical Center - Moses Campus Recruiting
Bronx, New York, United States, 10467-2490
Contact: Madhur K. Garg    718-920-4361    aecc@aecom.yu.edu   
Principal Investigator: Madhur K. Garg         
Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Madhur Garg, MD Associate Clinical Director

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Responsible Party: Madhur Garg, Associate Director, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT04147806     History of Changes
Other Study ID Numbers: 2016-6545
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dexamethasone
Tamsulosin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents