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New treatment option for Prostate Cancer
Official title Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
ClinicalTrials.gov ID: NCT06235697
What this study is testing
What is ADT?
ADT is an investigational medicine, being studied as a potential treatment for prostate cancer.
Also referred to as Androgen Deprivation Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is being done to answer the following question: Is the strategy to give higher doses of radiotherapy treatment over a shorter period of time using special equipment and fewer treatments (also known as Stereotactic Body Radiation Therapy or SBRT) as effective as usual external radiation therapy given with a brachytherapy boost (which involves radiation sources inserted directly into the prostate)?
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months
- Participants with unfavourable risk prostate cancer are eligible according to the following NCCN classification guidelines (Version 4.2022 - May 10...
- Unfavourable-intermediate risk - has one or more of the following:
- 2 or 3 Intermediate Risk Factors (IRFs): cT2b-cT2c, Gleason 7 (grade group 2 or 3), and/or PSA 10-20 ng/ml;
- Gleason 4+3 (grade group 3)
You likely can't join if
- Prior pelvic radiotherapy
- Contraindication to radical prostate radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion or brachytherapy implant) and/or prior or current bleeding diathesis
- Prior steam vaporization (Rezum), transurethral resection of the prostate (TURP), prostatectomy (simple or radical), or any ablative therapy to the...
- Prostate volume \> 60cc before start of androgen deprivation therapy
- Anatomy that would preclude precise brachytherapy implant (such as arch interference or large median lobe)
See the full eligibility criteria
- Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months
- Participants with unfavourable risk prostate cancer are eligible according to the following NCCN classification guidelines (Version 4.2022 - May 10, 2022):
- Unfavourable-intermediate risk - has one or more of the following:
- 2 or 3 Intermediate Risk Factors (IRFs): cT2b-cT2c, Gleason 7 (grade group 2 or 3), and/or PSA 10-20 ng/ml;
- Gleason 4+3 (grade group 3)
- \> 50% biopsy cores positive
- High risk - has one of the following:
- cT3a
- Gleason 8-10 (grade group 4 or 5)
- PSA \> 20 ng/ml
- Very-high risk - has at least one of the following:
- cT3b-cT4
- Primary Gleason pattern 5
- 2 or 3 high risk features: cT3a, Gleason 8-10 (grade group 4 or 5), and/or PSA \> 20 ng/ml
- \> 4 cores with Gleason 8-10 (grade group 4 or 5)
- ECOG performance status of 0, 1 or 2
- Participants must be ≥ 18 years of age
- Judged to be medically fit for brachytherapy
- Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English, French or Spanish
- Participants consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their...
- Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events...
- In accordance with CCTG policy, protocol treatment is to begin within 12 weeks of participant enrollment
- Participants must be willing to take precautions to prevent pregnancy while on study
- ADT (LHRH agonists, antagonists, or anti-androgens) for prostate cancer is permitted for up to 30 days before study enrollment
- 5-alpha reductase inhibitors (5-ARI) are allowed, but baseline PSA will be corrected if 5-ARI use occurs within 6 months of enrollment
- Participants may NOT have received other therapies including chemotherapy, PARPi, radioligand or other investigational drugs for prostate cancer
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Urinary function defined as International Prostate Symptom Score (IPSS) \< 20. Alpha blockers are allowed to treat baseline urinary function
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Prior pelvic radiotherapy
- Contraindication to radical prostate radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion or brachytherapy implant) and/or prior or current bleeding diathesis
- Prior steam vaporization (Rezum), transurethral resection of the prostate (TURP), prostatectomy (simple or radical), or any ablative therapy to the prostate (cryotherapy, HIFU, TULSA, focal laser ablation, photodynamic...
- Prostate volume \> 60cc before start of androgen deprivation therapy
- Anatomy that would preclude precise brachytherapy implant (such as arch interference or large median lobe)
- Evidence of castrate resistance (defined as a rising PSA \> 3.0 ng/ml while testosterone is \< 3.0 nmol/l)
- Hip prosthesis (unilateral hip replacement is allowed if dose constrains can be reasonably achieved.
The study team makes the final eligibility decision.
Where it's taking place
- Antioch, California, United States
- Dublin, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Modesto, California, United States
- Oakland, California, United States
- Redwood City, California, United States
- Richmond, California, United States
- Rohnert Park, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- San Jose, California, United States
- San Leandro, California, United States
- San Rafael, California, United States
- Santa Clara, California, United States
- Santa Rosa, California, United States
- South San Francisco, California, United States
- Stockton, California, United States
- Vacaville, California, United States
+ 25 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Antioch, California, United States; Dublin, California, United States; Fremont, California, United States; Fresno, California, United States; Modesto, California, United States; Oakland, California, United States and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.