Bicalutamide + Radiation Therapy for Prostate Cancer

(BiolenRT Trial)

Overseen By Theresa Cooley-Zgela, RN

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Alessa Therapeutics Inc.

Must be taking: Anti-androgens

Must not be taking: 5 alpha reductase inhibitors

Disqualifiers: Prior radiotherapy, Prior surgery, others

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

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if targeted delivery of the anti-androgen agent bicalutamide, combined with radiation therapy, can effectively treat localized prostate cancer. Researchers seek to discover if this approach can replace the usual systemic hormone therapy, which affects the whole body, in prostate cancer treatment. The trial targets patients with localized prostate cancer who are considering radiation therapy and may be hesitant about standard hormone treatments. Eligible participants include those with biopsy-confirmed prostate cancer diagnosed as intermediate or high-risk, who opt not to receive standard hormone treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop all current medications, but you cannot use 5 alpha reductase inhibitors (like Finasteride or Dutasteride) within 3 months before screening.

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

Research has shown that bicalutamide, a drug for prostate cancer, is generally safe. In some studies, participants taking bicalutamide reported hot flashes as the most common side effect. This drug is already part of other prostate cancer treatments, so doctors have a good understanding of its safety.

Stereotactic Body Radiation Therapy (SBRT) also appears safe. Studies have demonstrated it as a safe option for treating localized prostate cancer. Patients who received SBRT experienced manageable side effects, and most remained cancer-free for several years after treatment.

Both treatments have been used in various situations, and evidence suggests they are well-tolerated, with manageable side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about the combination of Bicalutamide and Stereotactic Body Radiation Therapy because it introduces a novel approach to treating prostate cancer. Unlike traditional hormone therapies that can have widespread effects, this treatment uses a localized delivery of Bicalutamide through the Biolen implant, which targets the cancer more directly with fewer side effects. Additionally, the precise nature of Stereotactic Body Radiation Therapy allows for high doses of radiation to be administered with pinpoint accuracy, maximizing effectiveness while minimizing damage to surrounding healthy tissue. This combination has the potential to improve outcomes and reduce treatment times compared to the current standard of care.

What evidence suggests that Bicalutamide + Radiation Therapy could be effective for prostate cancer?

Research has shown that bicalutamide, when combined with standard treatments, can help prostate cancer patients live longer without disease progression. One study found it significantly reduced the risk of PSA levels doubling and cancer spreading to the bones, thereby slowing the cancer's growth and spread.

Stereotactic Body Radiation Therapy (SBRT) also proves effective, offering high survival rates over five years and relieving symptoms without severe side effects. Studies have demonstrated that SBRT is a safe and effective treatment for localized prostate cancer, with a strong long-term safety record. In this trial, participants will receive a combination of bicalutamide and SBRT, which may enhance the effectiveness of these treatments against prostate cancer. ^{4 6 7 8 9}

Who Is on the Research Team?

Deborah Citrin, MD

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Men over 18 with intermediate or high-risk localized prostate cancer suitable for radiation and anti-androgen therapy, but who refuse systemic ADT. They must have MRI-detected, biopsy-proven cancer and not used certain medications recently. Men with prior prostate cancer treatments or severe urinary symptoms are excluded.

Inclusion Criteria

I have intermediate or high-risk prostate cancer and refuse hormone therapy.

I am older than 18 years.

I have prostate cancer that is still contained within the prostate and requires radiation and hormone therapy.

Exclusion Criteria

I haven't used medications like Finasteride or Dutasteride for more than 3 months in the last 2 years.

I am at high risk and open to hormone therapy for my cancer.

I cannot have an MRI due to a medical device I have or another reason.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline multiparametric MRI of the prostate and placement of Biolen implants

1 week

1 visit (in-person)

Treatment

Participants receive standard of care radiation therapy

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including multiparametric MRIs and clinical labs

24 months

Multiple visits (in-person)

Long-term follow-up (optional)

Participants may be offered enrollment on long-term follow-up protocols

What Are the Treatments Tested in This Trial?

Interventions

• Bicalutamide
• Stereotactic Body Radiation Therapy

Trial Overview The trial is testing the use of Bicalutamide implants (Biolen) combined with Stereotactic body radiation therapy as an alternative to standard Androgen Deprivation Therapy in treating localized prostate cancer.

How Is the Trial Designed?

Group I: Biolen+Radiation Therapy Experimental Treatment 2 Interventions

Localized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy

Bicalutamide is already approved in European Union, United States, Japan, Canada for the following indications:

Approved in European Union as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Approved in United States as Casodex for:

• Metastatic prostate cancer

Approved in Japan as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Approved in Canada as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Who Is Running the Clinical Trial?

Alessa Therapeutics Inc.

Lead Sponsor

Trials

3

Recruited

60+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22129214/

final results from the bicalutamide Early Prostate Cancer ... Results: Overall, at a median follow-up of 9.7 years, bicalutamide significantly improved PFS (hazard ratio 0.85, 95% confidence interval 0.79-0.91; P= 0.001).

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1569905602000830

Results from the Bicalutamide ('Casodex') EPC Programme In addition, bicalutamide 150 mg plus standard care reduced the risk of PSA doubling by 59% (p⪡0.0001), and the incidence of bone metastases by 33% (p<0.0001), ...

3. cancer.gov cancer.gov/news-events/cancer-currents-blog/2017/androgen-deprivation-therapy-prostate

Androgen Deprivation Therapy for Recurrent Prostate ... The overall survival rate among patients in the bicalutamide group at 12 years was 76.3%, compared with 71.3% in the placebo group—a ...

4. drugs.com drugs.com/medical-answers/effective-casodex-bicalutamide-prostate-cancer-3554626/

How effective is Casodex for prostate cancer? leuprolide + flutamide treatment increased survival time by 7 months which was a 25% improvement. Another clinical trial was completed comparing ...

5. eu-openscience.europeanurology.com eu-openscience.europeanurology.com/article/S1569-9056(02)00083-0/fulltext

Immediate Therapy in Early Prostate Cancer: Results from ... In addition, bicalutamide 150mg plus standard care reduced the risk of PSA doubling by 59% (p⪡0.0001), and the incidence of bone metastases by 33% (p<0.0001), ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9510340/

Casodex (bicalutamide) 150-mg monotherapy compared ... Bicalutamide 150-mg monotherapy provides a similar survival outcome to castration in previously untreated patients with nonmetastatic advanced prostate cancer.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/020498s028lbl.pdf

CASODEX (bicalutamide) tablet, for oral use In patients with advanced prostate cancer treated with CASODEX in combination with an LHRH analog, the most frequent adverse reaction was hot flashes (53%). In ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.122

Outcomes, frailty status, and body composition of men with ... Bicalutamide and dutasteride was generally safe and feasible in a cohort of HSPC with increased pre-treatment frailty and sarcopenia.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01200810

Bicalutamide and RO4929097 in Treating Patients With ... This partially randomized phase II trial is studying how well giving bicalutamide together with RO4929097 works in treating patients with previously treated ...