2592 Participants Needed

Androgen-Deprivation + Radiation Therapy for Prostate Cancer

Recruiting at 533 trial locations
Age: 18+
Sex: Male
Trial Phase: Phase 3
Sponsor: Radiation Therapy Oncology Group
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications like finasteride 30 days before joining and dutasteride 90 days before joining. If you are on hormonal therapy or certain other prostate cancer treatments, you may need to stop those as well. It's best to discuss your current medications with the trial team to see if any changes are needed.

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

Research shows that combining androgen deprivation therapy (ADT) with radiation therapy is beneficial for patients with intermediate- and high-risk prostate cancer, improving survival rates and outcomes.12345

Is androgen-deprivation therapy combined with radiation therapy generally safe for humans?

Androgen-deprivation therapy (ADT) combined with radiation therapy is generally safe but can have side effects affecting various body systems, including weight gain, loss of libido, hot flashes, and impacts on metabolism, muscles, heart, brain, and sexual health. These side effects are manageable with proper monitoring and care.678910

How is the treatment of androgen-deprivation therapy combined with radiation therapy unique for prostate cancer?

This treatment is unique because it combines androgen-deprivation therapy, which reduces male hormones that can fuel prostate cancer growth, with radiation therapy to enhance the effectiveness of the radiation. This combination has been shown to improve survival in intermediate and high-risk prostate cancer patients compared to radiation alone.111121314

Research Team

MR

Mack Roach, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Men with moderate to high-risk prostate cancer, confirmed by biopsy within the last 180 days. They should have a PSA level under 50 ng/mL and no bone metastases. Men previously on active surveillance for low risk prostate cancer who now have higher risk disease may also join if re-biopsied within 180 days. No prior pelvic radiation or radical prostate surgery is allowed, and they must be willing to use contraception.

Inclusion Criteria

I was diagnosed with prostate cancer at moderate to high risk of coming back within the last 6 months.
ANC ≥ 1,500/mm³
Baseline serum PSA value performed within 120 days prior to registration
See 9 more

Exclusion Criteria

I am not willing or able to use birth control.
I have had radiation to my pelvis, seed implants in my prostate, or both testicles removed.
I have had a condition where my lymphocytes grow abnormally.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Androgen-Deprivation Therapy

Participants receive neoadjuvant androgen-deprivation therapy comprising bicalutamide or flutamide and LHRH agonist/antagonist therapy for 6 months

6 months

Radiotherapy

Participants undergo radiotherapy, either high-dose radiotherapy of the prostate and seminal vesicles or whole-pelvic radiotherapy, for approximately 9 weeks

9 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year with decreasing frequency

Treatment Details

Interventions

  • Androgen-Deprivation Therapy
  • Radiation Therapy
Trial OverviewThis phase III trial is testing whether combining androgen-deprivation therapy (which lowers male hormones) with whole-pelvic radiotherapy (a type of radiation that targets the entire pelvic area) is effective in treating patients with prostate cancer compared to other treatments.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm IIExperimental Treatment1 Intervention
Patients undergo whole-pelvic radiotherapy (WPRT)\* (3D-CRT or IMRT) once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo brachytherapy as in arm I.
Group II: Arm IActive Control1 Intervention
Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using intensity-modulated radiotherapy (IMRT)\* or 3D-conformal radiation therapy (3D-CRT)\* once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo permanent prostate implant (PPI) brachytherapy or high-dose rate brachytherapy (I 125 or Pd 103 may be used as the radioisotope).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Radiation Therapy Oncology Group

Lead Sponsor

Trials
191
Recruited
64,900+

NRG Oncology

Collaborator

Trials
242
Recruited
105,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

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.
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]
In a study of 373 intermediate-risk prostate cancer patients treated with radiotherapy over 14 years, those aged 70 or younger who received radiotherapy alone had a higher risk of biochemical failure compared to those who received combined radiotherapy and androgen deprivation therapy (ADT).
The results suggest that short-term ADT may be beneficial for younger patients with favorable intermediate-risk prostate cancer, as it improved biochemical relapse-free survival from 82.1% to 94.0% compared to radiotherapy alone.
Radiotherapy with or without androgen deprivation therapy in intermediate risk prostate cancer?Amit, U., Lawrence, YR., Weiss, I., et al.[2020]
In a study of 18,598 men with favorable intermediate-risk prostate cancer, adding androgen-deprivation therapy (ADT) to modern dose-escalated radiotherapy (RT) did not improve overall survival rates, with 8-year survival at 77.7% for ADT plus RT and 78.4% for RT alone.
The findings suggest that for patients with favorable intermediate-risk prostate cancer, using dose-escalated RT alone may be a reasonable treatment option, as ADT did not show survival benefits and carries potential side effects.
Evaluation of the effectiveness of adding androgen deprivation to modern dose-escalated radiotherapy for men with favorable intermediate-risk prostate cancer.Falchook, AD., Basak, R., Mohiuddin, JJ., et al.[2018]

References

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]
Radiotherapy with or without androgen deprivation therapy in intermediate risk prostate cancer? [2020]
Androgen Deprivation Therapy Combined With Particle Therapy for Prostate Cancer: A Systematic Review. [2022]
Role of androgen deprivation therapy in early salvage radiation among patients with prostate-specific antigen level of 0.5 or less. [2021]
Evaluation of the effectiveness of adding androgen deprivation to modern dose-escalated radiotherapy for men with favorable intermediate-risk prostate cancer. [2018]
Initial results of a randomized phase III trial of high dose image guided radiation with or without androgen deprivation therapy for intermediate-risk prostate cancer. [2019]
Androgen deprivation therapy toxicity and management for men receiving radiation therapy. [2021]
Effects of Androgen Deprivation Therapy on Prostate Cancer Outcomes According to Competing Event Risk: Secondary Analysis of a Phase 3 Randomised Trial. [2023]
Dose-escalated radiation therapy for intermediate-risk prostate cancer: patient selection for androgen deprivation therapy using percentage of positive cores. [2022]
Phase II Study of ENZAlutamide Combined With Hypofractionated Radiation Therapy (ENZART) for Localized Intermediate Risk Prostate Cancer. [2022]
Androgen deprivation therapy and radiotherapy in intermediate-risk prostate cancer: A systematic review and meta-analysis. [2023]
The androgen receptor for the radiation oncologist. [2015]
Management of the side effects of androgen deprivation therapy in men with prostate cancer. [2019]
External beam radiation therapy for clinically localized prostate cancer: when and how we optimize with concurrent hormonal deprivation. [2011]