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A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Androgen deprivation therapy (ADT)
Brachytherapy
Hypofractionated pelvic External beam radiation
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Hypofractionated Pelvic Radiation, Brachytherapy Boost, NCCN High-Risk Prostate Cancer, Low-Intermediate Risk Decipher Genomic Score, Androgen Deprivation, 21-405

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically-proven diagnosis of prostate adenocarcinoma
  • Clinical stage T3-4 or Gleason score 8-10 or PSA >20 ng/ml

    °If radiographic T3-T4 is the only high-risk factor, it must be "consistent with" or >90% probability of having T3-T4 disease determined by the reading radiologist.

  • Decipher genomic score ≤0.6
  • Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)
  • Age ≥18
  • KPS ≥70 or ECOG 0-2
  • Estimated life expectancy >5 years
  • Baseline prostate volume ≤90 cc
  • Baseline IPSS ≤20
  • No contraindications to ADT, brachytherapy, or pelvic external beam radiation therapy as determined by the treating radiation oncologist per standard practice
  • Patients who have already started ADT consisting of bicalutamide 50 mg PO daily with leuprolide or an equivalent GnRH analogue are eligible if given for ≤ 60 days prior to registration

Exclusion Criteria:

  • Regional lymph node or metastatic disease
  • Prior pelvic radiation
  • Prior prostate surgery (including TURP or cryosurgery)
  • Prior history of inflammatory bowel disease
  • Unable to undergo anesthesia or brachytherapy
  • Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hormone Therapy and Radiation

Arm Description

Patients enrolled in this study will receive ADT for 6 months which will consist of bicalutamide 50 mg PO daily starting approximately 1-2 weeks before leuprolide 22.5mg injected every 3 months. The HDR prostate brachytherapy procedure will be performed approximately 3 months after starting ADT to allow for potential radiosensitization and cytoreduction. Approximately 4 weeks after the HDR boost, patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.

Outcomes

Primary Outcome Measures

Distant metastatic disease-free (DMF) rate
Time to distant metastases will be estimated from the date of enrollment until distant metastases

Secondary Outcome Measures

Pathological response rate
Cumulative incidence of biochemical failure
Overall survival rate
Acute and late physician-scored toxicity
Using CTCAE v5.0. NCI Common Toxicity Criteria. The NCI scales are simple to complete and provide a means for assessing patient symptoms. Only the CTCAE v 5.0 will be used in toxicity grading.

Full Information

First Posted
October 19, 2021
Last Updated
October 19, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05100472
Brief Title
A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer
Official Title
Phase II Trial of Short Course Androgen Deprivation, Hypofractionated Pelvic Radiation and a Brachytherapy Boost for NCCN High-Risk Prostate Cancer With Low-Intermediate Risk Decipher Genomic Score
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
October 19, 2024 (Anticipated)
Study Completion Date
October 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to find out whether combining a shorter than standard course of ADT with standard prostate brachytherapy and hypofractionated external beam radiation therapy is a safe and effective way to prevent high-risk prostate cancer from coming back and/or spreading to other parts of the body.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Hypofractionated Pelvic Radiation, Brachytherapy Boost, NCCN High-Risk Prostate Cancer, Low-Intermediate Risk Decipher Genomic Score, Androgen Deprivation, 21-405

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This is a phase II single arm trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hormone Therapy and Radiation
Arm Type
Experimental
Arm Description
Patients enrolled in this study will receive ADT for 6 months which will consist of bicalutamide 50 mg PO daily starting approximately 1-2 weeks before leuprolide 22.5mg injected every 3 months. The HDR prostate brachytherapy procedure will be performed approximately 3 months after starting ADT to allow for potential radiosensitization and cytoreduction. Approximately 4 weeks after the HDR boost, patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.
Intervention Type
Biological
Intervention Name(s)
Androgen deprivation therapy (ADT)
Intervention Description
ADT will include bicalutamide 50 mg PO daily started 1-2 weeks before leuprolide 22.5mg IM or SQ delivered every 3 months x 2. Bicalutamide will be continued through radiation and then discontinued on the day of the last fraction. Leuprolide can be given at different doses, but must be given for a total planned duration of 6 months.
Intervention Type
Radiation
Intervention Name(s)
Brachytherapy
Intervention Description
After approximately 3 months (+/- 1 month) of neoadjuvant ADT, patients will undergo general anesthesia for outpatient transperineal high dose rate (HDR) interstitial prostate brachytherapy implant.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated pelvic External beam radiation
Intervention Description
Patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.
Primary Outcome Measure Information:
Title
Distant metastatic disease-free (DMF) rate
Description
Time to distant metastases will be estimated from the date of enrollment until distant metastases
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Pathological response rate
Time Frame
Between 24-36 months after radiation
Title
Cumulative incidence of biochemical failure
Time Frame
3 years
Title
Overall survival rate
Time Frame
3 years
Title
Acute and late physician-scored toxicity
Description
Using CTCAE v5.0. NCI Common Toxicity Criteria. The NCI scales are simple to complete and provide a means for assessing patient symptoms. Only the CTCAE v 5.0 will be used in toxicity grading.
Time Frame
3 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically-proven diagnosis of prostate adenocarcinoma Clinical stage T3-4 or Gleason score 8-10 or PSA >20 ng/ml °If radiographic T3-T4 is the only high-risk factor, it must be "consistent with" or >90% probability of having T3-T4 disease determined by the reading radiologist. Decipher genomic score ≤0.6 Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) Age ≥18 KPS ≥70 or ECOG 0-2 Estimated life expectancy >5 years Baseline prostate volume ≤90 cc Baseline IPSS ≤20 No contraindications to ADT, brachytherapy, or pelvic external beam radiation therapy as determined by the treating radiation oncologist per standard practice Patients who have already started ADT consisting of bicalutamide 50 mg PO daily with leuprolide or an equivalent GnRH analogue are eligible if given for ≤ 60 days prior to registration Exclusion Criteria: Regional lymph node or metastatic disease Prior pelvic radiation Prior prostate surgery (including TURP or cryosurgery) Prior history of inflammatory bowel disease Unable to undergo anesthesia or brachytherapy Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Gorovets, MD
Phone
212-639-3983
Email
gorovetd@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Deaglan McHugh, MD
Phone
631-212-6320
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Gorovets, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Gorovets, MD
Phone
212-639-3983
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Gorovets, MD
Phone
212-639-3983
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Gorovets, MD
Phone
212-639-3983
Facility Name
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Gorovets, MD
Phone
212-639-3983
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Gorovets, MD
Phone
212-639-3983
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Gorovets, MD
Phone
212-639-3983
First Name & Middle Initial & Last Name & Degree
Deaglan McHugh, MD
Phone
631-212-6320
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Gorovets, MD
Phone
212-639-3983

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer

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