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Hypofractionated Radiation Therapy + Eligard for Prostate Cancer (PROMPT Trial)

Phase 2
Recruiting
Led By Luis Souhami, MD
Research Sponsored by Luis Souhami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the end of radiotherapy up to five years
Awards & highlights

PROMPT Trial Summary

This trial is testing whether a new, more precise form of radiotherapy called MR-guided focal laser ablation (FLA) is more effective than the current standard of care for treating high-risk prostate cancer.

Who is the study for?
Men over 18 with high-risk prostate cancer post-prostatectomy, having negative lymph nodes and no bone metastases. Eligible participants must have a stable blood count, normal liver function, and not received prior pelvic radiotherapy or hormone therapy. They should be in good physical condition (Zubrod Performance Status 0-1) and free from severe medical conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing the effectiveness of postoperative hypofractionated radiation therapy combined with LHRH agonist therapy using Eligard in men who've had surgery for high-risk prostate cancer. It aims to see if this combination can reduce the risk of cancer returning by monitoring PSA levels.See study design
What are the potential side effects?
Potential side effects may include typical reactions to radiation like skin irritation, fatigue, urinary issues, bowel changes, as well as those related to hormone therapy such as hot flashes, sexual dysfunction, and possible impacts on heart health.

PROMPT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had prostate surgery, my cancer hasn't spread to lymph nodes, and my PSA is rising but below 2.0 ng/ml.
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My blood counts meet the required levels for treatment.
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I had prostate surgery for high-risk cancer and my PSA is below 0.4 ng/ml.
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I've had a full physical and rectal exam in the last 90 days.
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I am 18 years old or older.
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I can carry out all my normal activities without help.

PROMPT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the end of radiotherapy up to five years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the end of radiotherapy up to five years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute Patient Reported Morbidity in genito-urinary and gastrointestinal toxicity
Secondary outcome measures
Acute Physician-Reported Morbidity in genito-urinary and gastrointestinal toxicity
Late Patient-Reported Morbidity in genito-urinary and gastrointestinal toxicity
Other outcome measures
Late Physician-Reported Morbidity in genito-urinary and gastrointestinal toxicity

Side effects data

From 2019 Phase 4 trial • 107 Patients • NCT03035032
17%
Prostatic specific antigen increased
9%
Cough
8%
Back pain
8%
Hot flush
6%
Anaemia
6%
Upper respiratory tract infection
4%
Pneumonia
3%
Death
2%
Arthralgia
2%
Haemorrhage intracranial
2%
Neuralgia
1%
Chronic obstructive pulmonary disease
1%
Syncope
1%
Dysuria
1%
Epistaxis
1%
Pleural effusion
1%
Deep vein thrombosis
1%
Dyspnoea
1%
Septic shock
1%
Viral upper respiratory tract infection
1%
Femur fracture
1%
Spinal compression fracture
1%
Weight decreased
1%
Cardiac failure congestive
1%
Abdominal wall haematoma
1%
Anal hypoaesthesia
1%
Incarcerated inguinal hernia
1%
Inguinal hernia
1%
Inguinal hernia, obstructive
1%
Pancreatitis
1%
Proctalgia
1%
Vomiting
1%
Multiple organ dysfunction syndrome
1%
Peripheral swelling
1%
Appendicitis
1%
Gastroenteritis
1%
Sepsis
1%
Fluid overload
1%
Hyperglycaemia
1%
Muscular weakness
1%
Musculoskeletal chest pain
1%
Pain in extremity
1%
Prostate cancer metastatic
1%
Dementia
1%
Headache
1%
Spinal cord compression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Leuprolide Acetate 22.5 mg

PROMPT Trial Design

1Treatment groups
Experimental Treatment
Group I: Post-op IMRT & hormonal therapyExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Luis SouhamiLead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
440 Previous Clinical Trials
158,939 Total Patients Enrolled
3 Trials studying Prostate Cancer
2,286 Patients Enrolled for Prostate Cancer
SanofiIndustry Sponsor
2,160 Previous Clinical Trials
3,514,385 Total Patients Enrolled
47 Trials studying Prostate Cancer
6,364 Patients Enrolled for Prostate Cancer

Media Library

Postop Hypofractionated Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04249154 — Phase 2
Prostate Cancer Research Study Groups: Post-op IMRT & hormonal therapy
Prostate Cancer Clinical Trial 2023: Postop Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT04249154 — Phase 2
Postop Hypofractionated Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04249154 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for individuals to join this medical experiment?

"Affirmative. Clinicaltrials.gov reports this clinical trial is currently recruiting; it was initially listed on September 3rd 2019 and the details were most recently updated August 31st 2021. 77 participants are needed from two different sites for this experiment."

Answered by AI

What maladies are usually addressed with this therapeutic approach?

"This medicine is mainly used to treat advanced prostate cancer, but can also be prescribed for anemia and CPP (Central Precocious Puberty) as indicated by medical assessment."

Answered by AI

What are the potential risks associated with this therapeutic approach?

"This experimental treatment is estimated to have a safety rating of 2, as the trial is currently in Phase 2. This implies that there are data available from prior studies confirming its safety but no evidence pointing towards efficacy yet."

Answered by AI

Could you provide me with an overview of the other trials conducted in relation to this treatment?

"Currently, there are 64 trials exploring this treatment modality; 24 of which are in their final stage. Most studies related to this intervention take place in Duarte, California however 5355 sites have started research programs."

Answered by AI

How many participants are allowed to be involved in this experimental endeavor?

"Affirmative. Clinicaltrials.gov detail that this trial, initially posted on September 3rd 2019, is currently enrolling patients for participation. A total of 77 individuals must be administered the medication across 2 different clinical sites."

Answered by AI
Recent research and studies
~14 spots leftby Mar 2025