Radiation Therapy + Androgen Deprivation for Prostate Cancer

Recruiting at 459 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Radiation Therapy Oncology Group

Must not be taking: Finasteride, Dutasteride, Chemotherapy, others

Disqualifiers: Metastases, Invasive malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 4-6 months

1792 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy, it must be stopped within 3 months after prostatectomy. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment Radiation Therapy + Androgen Deprivation for Prostate Cancer?

Research shows that combining androgen deprivation therapy (ADT) with radiation therapy can improve outcomes for prostate cancer patients, especially those with intermediate- and high-risk cancer. Studies suggest that treating the pelvic lymph nodes with radiation, in addition to the prostate, may improve survival rates. ^{1 2 3 4 5}

Is the combination of radiation therapy and androgen deprivation generally safe for prostate cancer treatment?

The combination of radiation therapy and androgen deprivation for prostate cancer is generally considered safe, but it can have side effects. These may include impacts on metabolism, bones, heart, brain, and sexual health, which healthcare providers can monitor and manage. ^{1 5 6 7 8}

How is the treatment of Radiation Therapy + Androgen Deprivation for Prostate Cancer unique?

This treatment combines radiation therapy targeting both the prostate and pelvic lymph nodes with androgen deprivation therapy (hormone therapy that reduces male hormones), which has been shown to improve survival in prostate cancer patients, especially those with advanced or high-risk disease, compared to radiation alone. ^{1 2 4 6 9}

Research Team

Alan Pollack, MD

Principal Investigator

University of Miami

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

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

I received chemotherapy before or after my prostate surgery.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive prostate bed radiotherapy (PBRT) with or without pelvic lymph node radiotherapy (PLNRT) and short-term androgen deprivation therapy (STAD)

4-6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 years

3, 6, and 12 months after completion of radiation therapy, then every 6 months for 6 years, and annually thereafter

Treatment Details

Interventions

• AA
• LHRH agonist
• Pelvic Lymph Node Radiation Therapy
• Prostate Radiation Therapy

Trial Overview 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.

Participant Groups

Group I: PLNRT + PBRT + STADT Experimental Treatment 4 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 + STAD Experimental Treatment 3 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 Alone Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Radiation Therapy Oncology Group

Lead Sponsor

Trials

191

Recruited

64,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Cancer and Leukemia Group B

Collaborator

Trials

81

Recruited

118,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Findings from Research

In intermediate-risk prostate cancer patients (520 participants), androgen deprivation therapy (ADT) significantly improved biochemical relapse-free rates, particularly in those with multiple risk factors, indicating that short-term ADT (≤6 months) is beneficial.

For high-risk prostate cancer patients (555 participants), longer ADT durations (>6 months) were associated with better biochemical relapse-free rates, especially for those with multiple high-risk factors, suggesting that ADT for ≥21 months may be optimal when combined with high-dose proton beam therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Androgen Deprivation Therapy Combined with Proton Beam Therapy for Prostate Cancer: Results from a Multi-Institutional Study of the Japanese Radiation Oncology Study Group. Murakami, M., Ishikawa, H., Shimizu, S., et al.[2020]

Androgen deprivation therapy, often used alongside radiotherapy for localized and advanced prostate cancer, can lead to various side effects affecting multiple body systems, including metabolism, muscles, heart health, brain function, and sexual health.

This review emphasizes the importance of monitoring and managing the toxic effects of androgen deprivation therapy to enhance patient care and reduce these adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Androgen deprivation therapy toxicity and management for men receiving radiation therapy. Johnson, ME., Buyyounouski, MK.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ten-year outcomes of whole-pelvic intensity-modulated radiation therapy for prostate cancer with regional lymph node metastasis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Retrospective Feasibility Study of Salvage Pelvic Nodal Radiation in 6 Patients With Biochemical Failure Following Prostate Fossa Radiation: An Alternative to Androgen Deprivation Therapy (ADT). [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Survival Outcomes in Men with Unfavorable Intermediate-Risk and High-Risk Prostate Cancer Treated with Prostate-Only versus Whole Pelvic Radiation Therapy. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Optimal Androgen Deprivation Therapy Combined with Proton Beam Therapy for Prostate Cancer: Results from a Multi-Institutional Study of the Japanese Radiation Oncology Study Group. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Matched-pair analysis of prostate cancer patients with a high risk of positive pelvic lymph nodes treated with and without pelvic RT and high-dose radiation using high dose rate brachytherapy. [2006]

6. Spain pubmed.ncbi.nlm.nih.gov

External beam radiation therapy for clinically localized prostate cancer: when and how we optimize with concurrent hormonal deprivation. [2011]

7. Egypt pubmed.ncbi.nlm.nih.gov

Androgen deprivation therapy toxicity and management for men receiving radiation therapy. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Helical intensity-modulated radiotherapy of the pelvic lymph nodes with integrated boost to the prostate bed - initial results of the PLATIN 3 Trial. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

[Combined external radiotherapy and hormone therapy in patients with locally advanced prostate cancer: predictive factors of genitourinary toxicity]. [2011]