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New treatment option for Prostate Cancer
Official title Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer
ClinicalTrials.gov ID: NCT07325721
What this study is testing
- What it's testing
- This study is for adult men with previously untreated high risk, very high risk, or pelvic lymph node positive prostate cancer. The purpose of this study is to evaluate the safety and effectiveness of the combination of two emerging radiation treatment techniques (hypofractionated radiotherapy and microboost technique).
- Phase 2: a mid-size study of how well it works
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
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Biologically male patients aged 18 years and older.
- Ability to receive pelvic radiotherapy and be willing to adhere to the protocol regimen.
- Previously untreated prostate cancer (with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy). Prior...
You likely can't join if
- 1\. Concurrent use of testosterone supplementation unless discontinued by time of registration.
- 2\. Definitive radiologic evidence of metastatic disease outside of the pelvic nodes on conventional imaging (bone scan, CT scan, MRI).
- 3\. Prior pelvic radiotherapy. 4. Pre-existing conditions or overall health status which disqualifies the patient from curative intent-RT. Patients...
- 5\. Treatment with another investigational prostate cancer therapy within 12 months.
- 6\. Prior total prostatectomy, cryotherapy, high-intensity focused ultrasound, irreversible electroporation, MRI ablation, laser ablation...
- 7\. Prior or concurrent invasive pelvic malignancy (except non-melanomatous skin cancer) or lymphomatous or hematogenous malignancy, unless disease...
See the full eligibility criteria
Who can join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Biologically male patients aged 18 years and older.
- Ability to receive pelvic radiotherapy and be willing to adhere to the protocol regimen.
- Previously untreated prostate cancer (with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy). Prior transurethral resection of prostate (TURP) is permitted if 90 days or more prior...
- Localized or locally advanced prostate cancer meeting NCCN criteria for high risk, very high risk or non-metastatic, pelvic lymph node positive defined as having at least one or more of the following:
- PSA \>20 ng/mL prior to starting ADT.
- cT3a-T4 by digital exam or imaging.
- Gleason score of 8-10 (grade group 4 or 5).
- Staged as N1M0 by the treating investigator (pelvic lymph node positive, below the aortic bifurcation) based on soft tissue imaging within 120 days prior to registration (may include CT, MRI or PSMA PET/CT, of...
- History and physical exam within 120 days prior to registration.
- ECOG performance status 0-2.
- Be able to undergo MRI of the prostate and/or pelvis as a component of RT planning.
- Have at least one MRI visible target for microboost (PI-RADS≥ 4 version 2.0).
- Bone and soft tissue imaging as clinically indicated for staging within 120 days prior to registration.
- For males: use of condoms or other methods to ensure effective contraception with partner during radiation and for six months after completion of radiation.
- Adequate hematologic function within 120 days prior to registration as defined by:
- hemoglobin \>=9.0 g/dL independent of transfusion, and
- platelet count \>= 100,000 x 10 \^9/microliter independent of transfusion.
- Adequate hepatic function within 120 days prior to registration defined as total bilirubin \<2 x institutional upper limits of normal (ULN is 1.2 mg/dL). If labs are done at outside institution, total bilirubin should...
- Agreeable and eligible to receive long term (defined as 12-36 months) ADT as a standard component of prostate cancer therapy.
What rules you out
- 1\. Concurrent use of testosterone supplementation unless discontinued by time of registration.
- 2\. Definitive radiologic evidence of metastatic disease outside of the pelvic nodes on conventional imaging (bone scan, CT scan, MRI).
- 3\. Prior pelvic radiotherapy. 4. Pre-existing conditions or overall health status which disqualifies the patient from curative intent-RT. Patients with life expectancy less than 5 years are not eligible.
- 5\. Treatment with another investigational prostate cancer therapy within 12 months.
- 6\. Prior total prostatectomy, cryotherapy, high-intensity focused ultrasound, irreversible electroporation, MRI ablation, laser ablation, transurethral ultrasound ablation, aquablation directed towards the prostate for...
- 7\. Prior or concurrent invasive pelvic malignancy (except non-melanomatous skin cancer) or lymphomatous or hematogenous malignancy, unless disease free for a minimum of 5 years.
- 8\. Any condition that, in the opinion of the investigator, would preclude participation in this study.
- 9\. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 90 days prior to registration.
- 10\. Inability to undergo implantation of gold fiducial markers or rectal spacer gel.
- 11\. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen.
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
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 Charleston, South Carolina, United States. 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.