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Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer (PROMPT)

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Eligard

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Eligard, Post-Operative Hypofractionation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Histologically proven high risk (any of the following risk factors: surgical positive margins; extra-capsular extension; seminal vesicle involvement, Gleason score >7) adenocarcinoma of the prostate after a radical prostatectomy as primary treatment (adjuvant group), with pathologically negative lymph nodes dissection or clinically negative lymph nodes by imaging [pelvic and abdominal computed tomography (CT) scan, or magnetic resonance imaging (MRI)]. Lymphadenectomy is not mandatory. Any type of prostatectomy will be permitted. For this group of patients, the PSA level at time of entry must be below 0.4 ng/ml
Histologically proven adenocarcinoma after a radical prostatectomy with pathologically negative lymph nodes (lymphadenectomy is not mandatory) or clinically negative lymph nodes by imaging (pelvic and abdominal CT scan, or MRI or) and evidence of biochemical failure (defined as two consecutives rises of the PSA, at any PSA level). PSA upper limit post-prostatectomy must be below 2.0 ng/ml (salvage group). Any type of prostatectomy will be permitted
Negative bone metastases proven by bone scan. The use of proton emission tomography (PET) fluoride is allowed
History and physical examination (including digital rectal exam) within 90 days prior of registration
Adequate marrow reserve defined as: Hemoglobin ≥ 10 g/dl (patients may be transfused in order to achieve this level); Platelets ≥ 100 000 cells/mm3 and a white blood cell count of ≥ 4000 cells/ml3
AST or ALT <2 x the upper limit of normal
PSA and testosterone levels within one month of registration Age ≥ 18
Zubrod Performance Status 0-1
Patients must sign a study-specific consent form

Exclusion Criteria:

Previous exposure to androgen deprivation
Chemotherapy before or after prostatectomy
Prior pelvic radiotherapy
Previous malignancies (except non-melanomatous skin cancer) unless disease-free >5 years
Severe, active medical condition that makes the use of any of the therapies of the study not recommended

Sites / Locations

McGill University Health Centre- Cedars Cancer CentreRecruiting
McGill University Health Centre-Cedars Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Post-op IMRT & hormonal therapy

Arm Description

The protocol is designed to recruit patients who have undergone prostatectomy and high risk features of the disease were found post-operatively or for patients that, after prostatectomy, a PSA rise has been documented will be enrolled in the Phase II trial. Patients will receive Eligard injection 8-12 weeks before starting radiation. The second injection is given 12 weeks after the first one concomitant with radiation therapy.

Outcomes

Primary Outcome Measures

Acute Patient Reported Morbidity in genito-urinary and gastrointestinal toxicity

Number of Participants With Treatment-Related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events v.5.0 (CTCAE v5.0), Change From Baseline in genito-urinary and gastrointestinal toxicity up to 12 Weeks. Assessments will be collected at baseline and at the end of radiotherapy treatment and in follow-up.

Secondary Outcome Measures

Acute Physician-Reported Morbidity in genito-urinary and gastrointestinal toxicity

Number of Participants With Treatment-Related Adverse Events as Assessed by the CTCAE v5.0, Change From Baseline in genito-urinary and gastrointestinal toxicity up to 12 Weeks. Assessments will be collected before and at the end of radiotherapy treatment and in follow-up. For each symptom i.e., frequency, severity, the worst score experienced by the patient will be recorded.

Late Patient-Reported Morbidity in genito-urinary and gastrointestinal toxicity

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, Change From Baseline in genito-urinary and gastrointestinal toxicity. Assessments will be collected at baseline and up to 5 years of follow-up. For each symptom i.e., frequency, severity, the worst score experienced by the patient will be recorded will be collected before and at the end of radiotherapy treatment and in follow-up.

Full Information

NCT ID

NCT04249154

First Posted

August 15, 2019

Last Updated

August 31, 2021

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT04249154

Brief Title

Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer

Acronym

PROMPT

Official Title

Postoperative Hypofractionated Radiation Therapy and Hormonal Therapy in Patients With Prostate Cancer: A Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 3, 2019 (Actual)

Primary Completion Date

December 15, 2023 (Anticipated)

Study Completion Date

December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Prostate cancer is the second most common cancer among Canadian men of which approximately 20-30% present with high-risk tumour characteristic. Although surgery can be curative in patients evidencing pathological high-risk disease (extracapsular extension, seminal vesicle involvement, positive surgical margins), a large proportion will develop biochemical failure within years from the surgical procedure. The failure rate is even more pronounced in those patients that present with high prostate specific antigen (PSA) levels, pT3 disease, positive margins and Gleason score ≥8 with an estimated 75% failure rate at 10 years. Post-operative radiotherapy (RT) has been shown in three randomized trials to significantly decrease the biochemical failure rate and in one of the trials a survival benefit was also seen with the addition of post-operative RT and is considered by many investigators standard therapy in patients with pathological high-risks factors even in absence of biochemical failure.

Detailed Description

Although RT is known to potentially eradicate microscopic disease localized in the prostatic bed, the current dilemma is whether to deliver RT in the adjuvant setting (defined as the use of RT post-prostatectomy to patients at a higher risk of recurrence because of adverse pathological features prior to evidence of disease recurrence (i.e., with an undetectable PSA) or to use it as an early salvage therapy (defined as the use of RT in patients with rising PSA but no evidence of metastatic disease). There are several institutional retrospective reports on the use of RT as salvage therapy but no randomized trial has ever been completed. The best evidence available, however, supports early salvage RT as the best strategy to be used to maximize results. Our own group has shown excellent results using this approach in patients with low and intermediate risk disease and is currently exploring this approach in patients with high-risk disease. Hypofractionated RT offers a more convenient shorter course of treatment, reduces health-costs and appears to be as effective and safe as conventionally fractionated regimens. This Phase 2 trial will study the potential role of hypofractionated in the post-operative setting in patients with high-risk features with the primary objective of assessing toxicity from this approach. The use of androgen deprivation therapy in combination with RT in the primary treatment for patients with intermediate or high-risk prostate cancer is well established. The use of androgen suppression in the post-operative setting has been less explored and its definitive role has not been fully explored. This is a phase II clinical trial to assess the feasibility and overall toxicity of adding one injection of neo-adjuvant hormonal therapy starting 12 weeks before plus Hypofractionated Radiotherapy for four weeks concurrently with another injection of luteinizing hormone-releasing hormone (LHRH) analog in patients with post-operative setting in patients with high-risk features.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Eligard, Post-Operative Hypofractionation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Post-op IMRT & hormonal therapy

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Eligard

Other Intervention Name(s)

Radiation

Intervention Description

Eligard dose of 22.5mg given, 50Gy in 20 treatments of radiation therapy to start 12 weeks after first injection concurrent with second injection of Eligard

Primary Outcome Measure Information:

Title

Acute Patient Reported Morbidity in genito-urinary and gastrointestinal toxicity

Description

Time Frame

Up to 90 days after the end of radiation treatment

Secondary Outcome Measure Information:

Title

Acute Physician-Reported Morbidity in genito-urinary and gastrointestinal toxicity

Description

Time Frame

Up to 90 days after the end of radiation treatment

Title

Late Patient-Reported Morbidity in genito-urinary and gastrointestinal toxicity

Description

Time Frame

from the end of radiotherapy up to five years

Other Pre-specified Outcome Measures:

Title

Late Physician-Reported Morbidity in genito-urinary and gastrointestinal toxicity

Description

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, Change From Baseline in genito-urinary and gastrointestinal toxicity. Assessments will be collected at baseline and at the end of 5 years of follow-up. For each symptom i.e., frequency, severity, the worst score experienced by the patient will be recorded

Time Frame

From the end of radiation therapy + 90 days to the time of the first recorded late grade 3+ adverse event, assessed up to 5 years

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Trial is for prostate cancer.

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically proven high risk (any of the following risk factors: surgical positive margins; extra-capsular extension; seminal vesicle involvement, Gleason score >7) adenocarcinoma of the prostate after a radical prostatectomy as primary treatment (adjuvant group), with pathologically negative lymph nodes dissection or clinically negative lymph nodes by imaging [pelvic and abdominal computed tomography (CT) scan, or magnetic resonance imaging (MRI)]. Lymphadenectomy is not mandatory. Any type of prostatectomy will be permitted. For this group of patients, the PSA level at time of entry must be below 0.4 ng/ml Histologically proven adenocarcinoma after a radical prostatectomy with pathologically negative lymph nodes (lymphadenectomy is not mandatory) or clinically negative lymph nodes by imaging (pelvic and abdominal CT scan, or MRI or) and evidence of biochemical failure (defined as two consecutives rises of the PSA, at any PSA level). PSA upper limit post-prostatectomy must be below 2.0 ng/ml (salvage group). Any type of prostatectomy will be permitted Negative bone metastases proven by bone scan. The use of proton emission tomography (PET) fluoride is allowed History and physical examination (including digital rectal exam) within 90 days prior of registration Adequate marrow reserve defined as: Hemoglobin ≥ 10 g/dl (patients may be transfused in order to achieve this level); Platelets ≥ 100 000 cells/mm3 and a white blood cell count of ≥ 4000 cells/ml3 AST or ALT <2 x the upper limit of normal PSA and testosterone levels within one month of registration Age ≥ 18 Zubrod Performance Status 0-1 Patients must sign a study-specific consent form Exclusion Criteria: Previous exposure to androgen deprivation Chemotherapy before or after prostatectomy Prior pelvic radiotherapy Previous malignancies (except non-melanomatous skin cancer) unless disease-free >5 years Severe, active medical condition that makes the use of any of the therapies of the study not recommended

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luis Souhami, MD

Phone

514-934-4400

luis.souhami@muhc.mcgill.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Marianna Perna, CCRP

Phone

514-934-1934

Ext

43191

marianna.perna@muhc.mcgill.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis Souhami, MD

Organizational Affiliation

Radiation Oncologist

Official's Role

Principal Investigator

Facility Information:

Facility Name

McGill University Health Centre- Cedars Cancer Centre

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luis Souhami, M.D.

Phone

514-934-1934

Ext

43163

luis.souhami@muhc.mcgill.ca

First Name & Middle Initial & Last Name & Degree

Marianna Perna, CCRP

Phone

514-934-1934

Ext

43191

marianna.perna@muhc.mcgill.ca

Facility Name

McGill University Health Centre-Cedars Cancer Centre

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marianna Perna

Phone

514-934-1934

Ext

43191

marianna.perna@muhc.mcgill.ca

First Name & Middle Initial & Last Name & Degree

Tatiana Carvalho

Phone

514-934-1934

Ext

43698

tatiana.carvalho@muhc.mcgill.ca

First Name & Middle Initial & Last Name & Degree

Luis Souhami, MD

First Name & Middle Initial & Last Name & Degree

Fabio Cury, MD

First Name & Middle Initial & Last Name & Degree

Marie Duclos, MD

First Name & Middle Initial & Last Name & Degree

Sergio Faria, MD

12. IPD Sharing Statement

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Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer

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