Radiation + Hormone Therapy for Prostate Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must be taking: Androgen deprivation

Disqualifiers: Stage T3-4, Gleason 8+, PSA > 20, others

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

Compensation: Varies

Number of Visits: Unknown

105 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment combining radiation and hormone therapy for prostate cancer?

Research shows that combining androgen deprivation therapy (ADT) with radiation therapy improves survival in patients with intermediate- and high-risk prostate cancer. ADT is particularly beneficial when used with standard radiation doses, although its role with higher doses is less clear. ^{1 2 3 4 5}

Is the combination of radiation and hormone therapy generally safe for humans?

The combination of radiation therapy and hormone therapy (also known as androgen deprivation therapy or ADT) for prostate cancer has been studied, and while it can be effective, it is associated with side effects like weight gain, loss of libido, and hot flashes. These side effects can impact quality of life, so it's important to discuss potential risks with your doctor. ^{3 6 7 8 9}

How is the Radiation + Hormone Therapy treatment for prostate cancer different from other treatments?

This treatment combines androgen deprivation therapy (ADT) with advanced radiation techniques like proton beam therapy, which may offer increased efficacy and reduced side effects compared to traditional methods. The combination aims to improve disease control and survival, especially in intermediate- and high-risk prostate cancer patients. ^{1 3 10 11 12}

What is the purpose of this trial?

A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.

Research Team

Daniel Y. Song

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Men with intermediate-risk prostate cancer, specifically those with a clinical stage of T2b-T2c, PSA levels between 10-20 ng/mL, or Gleason score of 7. Participants must have chosen external beam radiation as their treatment and not had previous radical prostate surgery, chemotherapy within the last five years for another cancer, pelvic radiation therapy, metastases or certain other cancers.

Inclusion Criteria

My prostate cancer is confirmed and has not spread outside the prostate.

I have chosen external beam radiation to treat my prostate cancer.

Signed study-specific consent form prior to registration

Exclusion Criteria

My prostate cancer has a Gleason score of 8 or higher.

PSA > 20 ng/ml

IPSS (International Prostate Symptom Score) > 15

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Androgen Deprivation Therapy (ADT)

Participants receive androgen deprivation therapy for 4 months, starting at least 1 month prior to radiation therapy

4 months

Radiation Therapy

Participants undergo stereotactic body radiation therapy (SBRT) with 7.25 Gy every other day for a total of 5 fractions

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up points at 1, 2, 3, 6, 12, 18, 24, 30, 36 months, 4 years, and 5 years

5 years

Treatment Details

Interventions

• Androgen Deprivation Therapy (ADT)
• Radiation Therapy

Trial Overview The trial is testing how well men with prostate cancer respond to a combination of Androgen Deprivation Therapy (ADT) and Radiation Therapy. It aims to determine the effectiveness and tolerability of this combined approach in treating locally confined adenocarcinoma of the prostate.

Participant Groups

Group I: Radiation with Androgen Deprivation Therapy (ADT) Experimental Treatment 2 Interventions

This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.

Androgen Deprivation Therapy (ADT) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Androgen Deprivation Therapy for:

• Prostate cancer
• Metastatic prostate cancer
• Non-metastatic high-risk prostate cancer

Approved in United States as Androgen Deprivation Therapy for:

• Prostate cancer
• Metastatic prostate cancer
• Non-metastatic high-risk prostate cancer

Approved in Canada as Androgen Deprivation Therapy for:

• Prostate cancer
• Metastatic prostate cancer
• Non-metastatic high-risk prostate cancer

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Findings from Research

Androgen deprivation therapy (ADT) significantly enhances biochemical control when combined with dose-escalated radiation therapy (RT) for prostate cancer, as supported by recent phase III studies.

There is now randomized evidence supporting the use of ADT alongside RT in patients who have undergone prostatectomy, highlighting its ongoing importance in prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of Hormonal Therapy to Augment Radiation Therapy in Prostate Cancer: An Update. Kauffmann, G., Liauw, SL.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy with or without androgen deprivation therapy in intermediate risk prostate cancer? Amit, U., Lawrence, YR., Weiss, I., et al.[2020]

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]

Intensity-modulated radiotherapy (IMRT) combined with image-guided radiotherapy (IGRT) is recommended for high-dose treatments (≥76Gy) in prostate cancer, as it allows for effective dose escalation while managing toxicity.

Stereotactic body radiotherapy shows promise for prostate cancer treatment, but more extensive follow-up and phase III trials are needed to establish its efficacy and safety compared to established techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prostate cancer: what treatment techniques for which tumors? Ethical and methodological issues]. de Crevoisier, R., Castelli, J., Guérif, S., et al.[2018]

Prostate cancer treatment has advanced significantly from traditional 2D radiotherapy to more precise methods like intensity-modulated radiation therapy (IMRT) and stereotactic radiotherapy, enhancing treatment efficacy and reducing side effects.

Emerging techniques such as proton therapy and carbon therapy are being explored to further improve treatment outcomes, shorten treatment times, and minimize toxicity and costs for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What is the level of evidence of new techniques in prostate cancer radiotherapy?]. Khadige, M., Peiffert, D., Supiot, S.[2018]

References

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

The use of Hormonal Therapy to Augment Radiation Therapy in Prostate Cancer: An Update. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Radiotherapy with or without androgen deprivation therapy in intermediate risk prostate cancer? [2020]

3. 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]

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

Long-term outcomes of dose-escalated intensity modulated radiation therapy alone without androgen deprivation therapy for patients with intermediate and high-risk prostate cancer. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Androgen Deprivation Therapy Combined With Particle Therapy for Prostate Cancer: A Systematic Review. [2022]

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

Dose-escalated radiation therapy for intermediate-risk prostate cancer: patient selection for androgen deprivation therapy using percentage of positive cores. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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]

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

Short-term ADT and Dose-escalated IMRT in Patients With Intermediate-risk Prostate Cancer: Benefit or Caution? [2023]

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

Enzalutamide With Radiation Therapy for Intermediate-Risk Prostate Cancer: A Phase 2 Study. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Hormone and radiotherapy versus hormone or radiotherapy alone for non-metastatic prostate cancer: a systematic review with meta-analyses. [2022]

11. France pubmed.ncbi.nlm.nih.gov

[Prostate cancer: what treatment techniques for which tumors? Ethical and methodological issues]. [2018]

12. France pubmed.ncbi.nlm.nih.gov

[What is the level of evidence of new techniques in prostate cancer radiotherapy?]. [2018]