What side effects are associated with this type of intervention?

Androgen Deprivation Therapy (ADT) for prostate cancer, which reduces androgen levels, can cause side effects such as hot flashes, decreased libido, erectile dysfunction, fatigue, osteoporosis, and an increased risk of cardiovascular events. Radiation Therapy, which targets and kills tumor cells, can lead to urinary symptoms (frequency, urgency, discomfort), bowel symptoms (diarrhea, rectal bleeding), fatigue, and skin reactions in the treated area. Both treatments can significantly impact quality of life, and decisions should be made in consultation with a healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer that are similar to those being studied in trials include Androgen Deprivation Therapy (ADT) and Radiation Therapy. ADT reduces androgen levels using drugs like luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin) and antagonists (e.g., degarelix), as well as antiandrogens (e.g., flutamide, bicalutamide, enzalutamide). Radiation therapy, which kills tumor cells with high-energy x-rays, is often combined with ADT to improve treatment outcomes. These therapies are well-established and have been validated through numerous clinical trials.

What other types of research exist?

Promising novel alternatives to ADT and Radiation Therapy for prostate cancer patients include: <ol> <li>Enzalutamide: A second-generation androgen receptor inhibitor that has shown efficacy in both metastatic and nonmetastatic castration-resistant prostate cancer (CRPC).</li> <li>Abiraterone Acetate: Combined with prednisone, it inhibits androgen production and has been effective in advanced prostate cancer.</li> <li>Bipolar Androgen Therapy (BAT): Alternating high and low levels of testosterone to potentially restore sensitivity to androgen receptor-targeting therapies.</li> <li>PARP Inhibitors (e.g., Olaparib): Targeting DNA repair pathways, particularly effective in patients with specific genetic mutations like BRCA1/2.</li> <li>Immunotherapy (e.g., Sipuleucel-T): A cancer vaccine that stimulates the immune system to attack prostate cancer cells.</li> <li>Radioligand Therapy (e.g., Lutetium-177-PSMA): Targets prostate-specific membrane antigen (PSMA) to deliver radiation directly to cancer cells.</li> </ol>

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Radiation Therapy

Radiation Therapy + Androgen Deprivation for Prostate Cancer

Q: What is the mechanism of action of this treatment?

Androgen Deprivation Therapy (ADT) reduces androgen levels, which are hormones that stimulate prostate cancer cell growth, thereby slowing down or shrinking the cancer. Radiation Therapy uses high-energy x-rays to kill tumor cells directly, targeting the cancerous cells in the prostate and surrounding tissues to destroy them and prevent further growth. Understanding these mechanisms is crucial for prostate cancer patients as it helps them comprehend how these treatments control disease progression and what to expect in terms of outcomes and side effects.

Phase 3

Waitlist Available

Led By Alan Pollack, MD, PhD

Research Sponsored by Radiation Therapy Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

One of the following pathologic classifications: T3N0/Nx disease with or without a positive prostatectomy surgical margin; or T2N0/Nx disease with or without a positive prostatectomy surgical margin; Prostatectomy Gleason score of 9 or less; Zubrod Performance Status of 0-1; Age ≥ 18

No distant metastases, based upon specific diagnostic workup criteria

Must not have

A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer

Neoadjuvant chemotherapy before or after prostatectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to last follow-up. maximum follow-up at time of analysis was 10.5 years.

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This study is evaluating whether radiation therapy is more effective than short-term androgen deprivation therapy for prostate cancer.

Who is the study for?

Men aged 18+ who've had prostate surgery for adenocarcinoma of the prostate with no lymph node involvement or unknown status, a PSA level between 0.1 and <2.0 ng/mL post-surgery, and a Gleason score ≤9. They must not have distant metastases, prior pelvic radiotherapy, other recent cancers except certain skin cancers, severe co-morbidities like heart failure or inflammatory bowel disease, HIV/AIDS, or previous allergic reactions to study drugs.

What is being tested?

This phase III trial is testing whether radiation therapy alone is as effective as combining it with short-term hormone therapy in treating men whose PSA levels are rising after prostate cancer surgery. It compares pelvic lymph node radiation with/without prostate radiation against androgen deprivation therapy plus pelvic lymph node radiation.

What are the potential side effects?

Radiation may cause fatigue, skin changes at the treatment site, urinary issues like increased frequency or discomfort during urination; bowel problems such as diarrhea; erectile dysfunction. Hormone therapy can lead to hot flashes, reduced sex drive and energy levels; potential bone thinning over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has not spread to distant parts of my body.

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My prostate cancer was treated with surgery and either no lymph nodes were affected or their status is unknown.

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My PSA levels are between 0.1 and 2.0 ng/mL after my prostate surgery.

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My testosterone levels are within the normal range.

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My bone marrow is functioning well.

Exclusion Criteria

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

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I have a lump in the prostate area that might indicate cancer has returned.

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I received chemotherapy before or after my prostate surgery.

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I have not had certain cancer treatments like cryosurgery or radiation in the pelvic area recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to last follow-up. maximum follow-up at time of analysis was 10.5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to last follow-up. maximum follow-up at time of analysis was 10.5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to last follow-up. maximum follow-up at time of analysis was 10.5 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

Percentage of Participants Free From Progression (FFP) at 5 Years

Secondary study objectives

Percentage of Participants Alive (Overall Mortality)

Percentage of Participants Experiencing Grade 2+ and 3+ Adverse Events ≤ 90 Days of the Completion of Radiotherapy (RT)

Therapeutic radiology procedure

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: PLNRT + PBRT + STADTExperimental Treatment4 Interventions

Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).

Group II: PBRT + STADExperimental Treatment3 Interventions

Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).

Group III: PBRT AloneActive Control1 Intervention

Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

2006

N/A

~190

LHRH agonist

2000

Completed Phase 4

~2420

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Androgen Deprivation Therapy (ADT) reduces androgen levels, which are hormones that stimulate prostate cancer cell growth, thereby slowing down or shrinking the cancer. Radiation Therapy uses high-energy x-rays to kill tumor cells directly, targeting the cancerous cells in the prostate and surrounding tissues to destroy them and prevent further growth. Understanding these mechanisms is crucial for prostate cancer patients as it helps them comprehend how these treatments control disease progression and what to expect in terms of outcomes and side effects.