Local Ablative Therapy for Prostate Cancer

(PLATON Trial)

Recruiting at 18 trial locations

Overseen By Wendy Parulekar

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Canadian Cancer Trials Group

Must be taking: Zoladex

Disqualifiers: Castration resistant prostate cancer, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 years

409 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the effects of ablative therapy (radiation or surgery) to all sites of disease combined with standard treatments on prostate cancer, compared to the standard or usual treatments used to treat this disease.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it does require that Zoladex (a hormone therapy) be started within a specific timeframe related to the trial.

What data supports the effectiveness of the treatment Ablative Radiation Therapy for prostate cancer?

Research suggests that high-dose radiation therapy, including techniques like intensity-modulated radiation therapy, can benefit men with localized prostate cancer, improving outcomes when combined with long-term androgen deprivation therapy. ^{1 2 3 4 5}

Is local ablative therapy for prostate cancer safe?

The research articles provided do not contain specific safety data for local ablative therapy for prostate cancer or related treatments. ^{6 7 8 9 10}

How does the treatment for localized prostate cancer differ from other treatments?

Local ablative therapy for prostate cancer is unique because it uses minimally invasive techniques like cryotherapy and high-intensity focused ultrasound (HIFU) to target and destroy cancerous tissue, potentially reducing side effects compared to traditional surgery or radiation. This approach offers a middle ground between active surveillance and radical treatments, focusing on effective early cancer control with less impact on quality of life. ^{11 12 13 14 15}

Research Team

Patrick CF Cheung

Principal Investigator

Odette Cancer Centre, Sunnybrook Health Science Centre, Toronto, ON Canada

M. Tamim Niazi

Principal Investigator

The Jewish General Hospital, Montreal, QC Canada

Eligibility Criteria

Men over 18 with hormone-sensitive prostate cancer that has spread to no more than five places and hasn't become resistant to hormonal therapy. They should be in good physical condition, able to fill out questionnaires in English or French, and willing to use effective contraception. Those who've had certain previous treatments or have brain metastases can't join.

Inclusion Criteria

Bone scan within 42 days of randomization

My prostate cancer is adenocarcinoma without any small cell cancer.

I started or will start Zoladex within 12 weeks around my trial entry.

Exclusion Criteria

My prostate cancer has spread to pelvic lymph nodes only and hasn't been treated before.

I stopped my hormone therapy for cancer more than a year ago and it lasted less than 3 years.

My prostate cancer is growing despite low testosterone levels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard systemic therapy with or without ablative therapy (SBRT or surgery) to all sites of disease

6 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 years

Treatment Details

Interventions

• Ablative Radiation Therapy
• Standard of care

Trial Overview The trial is testing whether adding ablative therapy (targeted radiation or surgery) to standard care improves outcomes for men with limited-spread prostate cancer compared to standard care alone. Participants will be randomly assigned to one of the two approaches.

Participant Groups

Group I: Arm 2 (standard systemic therapy + ablative therapy)) Experimental Treatment 2 Interventions

Local Ablative therapy to all sites of disease (including untreated prostate primary) + Standard systemic therapy

Group II: Arm 1 (standard of care) Active Control 1 Intervention

Standard systemic therapy + Ablative therapy to untreated prostate primary for patients with low volume metastatic disease burden

Standard of care is already approved in United States, European Union for the following indications:

Approved in United States as Botulinum toxin injections for:

• Focal dystonia
• Segmental dystonia
• Cervical dystonia
• Blepharospasm

Approved in European Union as Botulinum toxin injections for:

• Primary cranial dystonia
• Cervical dystonia
• Writing dystonia

Approved in United States as Deep Brain Stimulation for:

• Primary generalized dystonia
• Cervical dystonia

Approved in European Union as Deep Brain Stimulation for:

• Primary generalized dystonia
• Cervical dystonia

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

TerSera Therapeutics LLC

Industry Sponsor

Trials

11

Recruited

1,300+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

Findings from Research

Minimally invasive local ablative therapies, such as cryotherapy and high-intensity focused ultrasound, offer an alternative to traditional radical therapies for men with localized prostate cancer, providing a balance between treatment and quality of life.

These therapies are generally well tolerated with lower side effects compared to surgery or radiation, but their long-term effectiveness in controlling cancer is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive ablative therapies for definitive treatment of localized prostate cancer in the primary setting. Lee, EW., Huang, WC.[2021]

Minimally-invasive ablative therapies like cryotherapy, high intensity focused ultrasound (HIFU), and photodynamic therapy provide effective early cancer control for localized prostate cancer while minimizing side effects, particularly genitourinary morbidity.

These treatments allow for focal therapy, targeting only the cancerous lesions in the prostate, which offers a less aggressive alternative compared to radical therapies and active surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally-invasive technologies in uro-oncology: the role of cryotherapy, HIFU and photodynamic therapy in whole gland and focal therapy of localised prostate cancer. Ahmed, HU., Moore, C., Emberton, M.[2021]

Recent advancements in radiation therapy techniques, such as Stereotactic Body Radiotherapy (SBRT), proton beam radiation, and high-dose-rate (HDR) brachytherapy, show promise in effectively treating prostate cancer while minimizing toxicity.

For high-risk prostate cancer, these new radiation modalities are often combined with regional radiation therapy to ensure comprehensive treatment, while non-radiation therapies like cryoablation and high-intensity focused ultrasound are still considered experimental for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging Technologies and Techniques in Radiation Therapy. Magnuson, WJ., Mahal, A., Yu, JB.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Hormonotherapy of advanced prostate cancer. [2020]

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

Radiation Therapy Oncology Group P-0014: a phase 3 randomized study of patients with high-risk hormone-naive prostate cancer: androgen blockade with 4 cycles of immediate chemotherapy versus androgen blockade with delayed chemotherapy. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Survival Among Men at High Risk of Disseminated Prostate Cancer Receiving Initial Locally Directed Radical Treatment or Initial Androgen Deprivation Therapy. [2021]

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

Radiation therapy in the management of locally advanced prostate cancer. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Locally advanced prostate cancer: effective treatments, but many adverse effects. [2013]

6. Canada pubmed.ncbi.nlm.nih.gov

Androgen deprivation therapy for patients with prostate carcinoma and Parkinson's disease: case report and review of literature. [2013]

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

Complications of androgen deprivation therapy in prostate cancer. [2009]

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

Entacapone and prostate cancer risk in patients with Parkinson's disease. [2015]

9. Germany pubmed.ncbi.nlm.nih.gov

Management of Pulse Generators in a Breast Cancer Patient with in Situ Subthalamic Nucleus Deep Brain Stimulation. [2019]

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

Supervised exercise therapy compared with no exercise therapy to reverse debilitating effects of androgen deprivation therapy in patients with prostate cancer: a systematic review and meta-analysis. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation. [2021]

12. Egypt pubmed.ncbi.nlm.nih.gov

Minimally invasive ablative therapies for definitive treatment of localized prostate cancer in the primary setting. [2021]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Minimally-invasive technologies in uro-oncology: the role of cryotherapy, HIFU and photodynamic therapy in whole gland and focal therapy of localised prostate cancer. [2021]

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

Emerging Technologies and Techniques in Radiation Therapy. [2018]

15. France pubmed.ncbi.nlm.nih.gov

[Multidisciplinary approach in the treatment of localized forms of cancer of the prostate]. [2006]