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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

Must not have

Severe, active medical condition that makes the use of any of the therapies of the study not recommended

Prior pelvic radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the end of radiotherapy up to five years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe health condition that makes study treatments unsafe for me.

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I have had radiation therapy to my pelvic area before.

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I have been treated with hormone therapy for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the end of radiotherapy up to five years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute Patient Reported Morbidity in genito-urinary and gastrointestinal toxicity

Secondary study objectives

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

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

Other study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met