Radiation + Hormone Therapy for Prostate Cancer

Not currently recruiting at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of radiation therapy and hormone therapy (Androgen Deprivation Therapy, or ADT) to evaluate its effectiveness and tolerability in treating prostate cancer. The researchers aim to determine if this combined approach can better manage prostate cancer that remains confined to the prostate. Men diagnosed with locally confined prostate cancer who meet specific risk criteria may qualify for this study. The trial seeks to provide new insights into treatment options for those who have chosen radiation as their treatment path. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to pioneering treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Androgen Deprivation Therapy (ADT) is usually well-tolerated for treating prostate cancer. Studies have found that ADT can improve certain cancer indicators in over 90% of patients and shrink tumors in 80% to 90% of cases. However, some men might experience side effects such as sexual problems and changes in appearance.

For Radiation Therapy, specifically Stereotactic Body Radiation Therapy (SBRT), research suggests it is safe with few side effects. It works effectively and does not increase the chance of cancer recurrence. Some people might experience urinary issues, but these are generally manageable.

Overall, both treatments show promise for prostate cancer, with some side effects to consider. It is important to discuss potential risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for prostate cancer, which often involve prolonged courses of radiation or hormone therapy alone, this new approach combines Androgen Deprivation Therapy (ADT) with a condensed schedule of high-dose radiation. Researchers are excited because this regimen uses stereotactic body radiation therapy (SBRT) to deliver precise, higher doses of radiation in just five sessions, potentially reducing the overall treatment time and improving convenience for patients. The study is also exploring whether this combination can enhance effectiveness while managing side effects, making it a promising option for patients.

What evidence suggests that radiation and hormone therapy might be an effective treatment for prostate cancer?

This trial will evaluate the combination of androgen deprivation therapy (ADT) and stereotactic body radiotherapy (SBRT) for prostate cancer. Research has shown that ADT effectively treats advanced prostate cancer by lowering male hormone levels, which slows cancer growth. Studies have demonstrated that men receiving ADT experience better cancer management and improved survival rates, with some research reporting a median survival of over six years.

SBRT is another promising treatment for prostate cancer. Research indicates that SBRT effectively reduces the risk of cancer recurrence and matches the effectiveness of other radiation therapies. In this trial, combining ADT and SBRT may offer a robust approach to managing prostate cancer by targeting cancer cells and slowing their growth. ^{2 6 7 8 9}

Who Is on the Research Team?

Daniel Y. Song

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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

PSA > 20 ng/ml

IPSS (International Prostate Symptom Score) > 15

Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

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A study of 341 CRPC patients concluded that survival benefit of 2 to 6 months was obtained by continued testicular androgen suppression [9]. Therefore, studies ...

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Hormone therapies, which are treatments that decrease androgen levels or block androgen action, can inhibit the growth of such prostate cancers.

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Results. Key issues were identified and are discussed: It was concluded that no additional ADT is recommended for low-risk prostate cancer patients, whereas for ...