Dose-Escalated Salvage Radiotherapy for Prostate Cancer

(MAPS Trial)

Overseen By Pavel Noa Hechevarria

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Androgen deprivation

Disqualifiers: Metastatic disease, Prior pelvic radiotherapy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 34 fractions (approximately 7 weeks)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates new methods to improve radiation treatment for prostate cancer that has recurred after surgery. Researchers are testing whether a higher dose of radiation, focused on specific tumor areas identified by MRI scans, can more effectively lower prostate-specific antigen (PSA) levels. The study also examines how certain biomarkers and circulating tumor cells in the blood might influence treatment outcomes. Men who have undergone prostate surgery, with a PSA level between 0.1 and 4.0 ng/mL and no distant cancer spread, are suitable candidates for this trial. As an unphased study, this trial offers patients the chance to contribute to pioneering research that could enhance future prostate cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had androgen deprivation therapy within the last 6 months, you cannot participate.

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

Research has shown that treatments like Mapped Tumor Salvage RT (MTSRT) are generally safe for patients. Studies have found this type of radiation therapy to be effective, and most patients tolerate it well. While many experience side effects after treatment, these typically improve within a year.

Patients who underwent similar radiation treatments have seen positive outcomes, with many remaining cancer-free for two to five years. This suggests that despite some initial discomfort, the long-term benefits are significant.

In summary, the treatment has demonstrated promising safety results, with manageable side effects for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mapped Tumor Salvage Radiotherapy (MTSRT) for prostate cancer because it takes a more targeted approach than the current standard treatments. Unlike the standard salvage radiation treatment that delivers a uniform dose, MTSRT uses advanced imaging to precisely identify tumor regions, allowing for a higher radiation dose specifically to the cancerous areas while sparing healthy tissue. This precision could enhance effectiveness and reduce side effects, offering a promising advancement in prostate cancer treatment.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that salvage radiotherapy (RT) can benefit prostate cancer patients whose cancer returns after surgery. Studies have found that 56.4% to 78.9% of patients experience a drop in prostate-specific antigen (PSA) levels after salvage RT, indicating effective treatment. Additionally, long-term research suggests that some patients have up to a 93% chance of remaining cancer-free for at least five years post-treatment. This trial will compare two approaches: Mapped Tumor Salvage RT (MTSRT), which targets higher doses of radiation to specific cancer areas, and Standard Salvage Radiation Treatment (SSRT). MTSRT may offer significant benefits due to its targeted approach. ^{1 3 6 7 8}

Who Is on the Research Team?

Matthew Abramowitz, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Men aged 35-85 with prostate cancer, who've had a prostatectomy and have PSA levels between 0.1 to 4.0 ng/mL within the last three months. They should not have distant metastatic disease or previous pelvic radiotherapy, must be at least three months post-surgery, and able to sign consent.

Inclusion Criteria

I have a detectable tumor in my prostate or nearby lymph nodes, measured recently.

My cancer has not spread far, except possibly to pelvic nodes.

I don't have any other active cancers except for non-spreading skin cancer or early CLL.

Exclusion Criteria

I haven't had hormone therapy for my cancer in the last 6 months, except as part of radiation treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MRI-mapped dose-escalated salvage radiotherapy post-prostatectomy

34 fractions (approximately 7 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 65 months

What Are the Treatments Tested in This Trial?

Interventions

• Mapped Tumor Salvage RT (MTSRT)
• Standard Salvage Radiation Treatment (SSRT)

Trial Overview The MAPS Trial is testing if increasing radiation doses directly to MRI-detected lesions in the prostate bed can improve initial response rates (lowering PSA to <0.1 ng/mL) compared to standard salvage radiation treatment.

How Is the Trial Designed?

Group I: Phase 3 - Arm II: Mapped Tumor Salvage RT (MTSRT) Experimental Treatment 1 Intervention

Phase 3 Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the Gross Tumor Volume (GTV) defined by functional imaging will receive 2.25 Gy per day for a total of 76.5 Gy (biological equivalent to 80 Gy in 2.0 Gy fractions assuming an α/β ratio of 3). this arm was continues as single arm phase 2

Group II: Phase 3 - Arm I: Standard Salvage Radiation Treatment (SSRT) Experimental Treatment 1 Intervention

Phase 3 total dose of 68 Gy will be delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes. this arm is closed

Group III: Phase 2: Mapped Tumor Salvage RT (MTSRT) Experimental Treatment 1 Intervention

Phase 2 Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the Gross Tumor Volume (GTV) defined by functional imaging will receive 2.25 Gy per day for a total of 76.5 Gy (biological equivalent to 80 Gy in 2.0 Gy fractions assuming an α/β ratio of 3).

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

The RAVES trial is a phase III study involving 470 patients with pT3 prostate cancer, comparing early salvage radiotherapy (SRT) triggered by rising PSA levels to standard adjuvant radiotherapy (ART) given within 4 months after surgery.

As of October 2013, 258 patients have been randomized, and the trial aims to determine if observation with early SRT is as effective as ART in preventing biochemical failure, with additional assessments on patient outcomes and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase III trial to investigate the timing of radiotherapy for prostate cancer with high-risk features: background and rationale of the Radiotherapy -- Adjuvant Versus Early Salvage (RAVES) trial. Pearse, M., Fraser-Browne, C., Davis, ID., et al.[2022]

In a study of 554 prostate cancer patients who received salvage radiotherapy (SRT) after surgery, escalating the radiation dose to 7000 cGy or more significantly improved progression-free survival compared to lower doses, with a median follow-up of 6.8 years.

Factors such as lower tumor stages and lower Gleason scores were also associated with better progression-free survival, but the study found no significant impact on overall survival, indicating the need for longer follow-up to fully understand the benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Dose Escalation on the Efficacy of Salvage Radiotherapy for Recurrent Prostate Cancer-A Risk-Adjusted, Matched-Pair Analysis. Böhmer, D., Siegmann, A., Scharl, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8766670/

Mapping of Recurrence Sites Following Adjuvant or ... Although salvage and adjuvant radiotherapy (RT) are effective in prostate cancer (PC) patients, 30%–40% of men will have disease progression.

2. sciencedirect.com sciencedirect.com/science/article/pii/S228788822500042X

Oncologic outcomes of salvage radiotherapy and ... Pooled incidence rates after LND and RT were as follows: prostate-specific antigen (PSA) response (56.4% vs. 78.9%), PSA progression (61.3% vs.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8833698/

Salvage Radiotherapy versus Observation for Biochemical ... Salvage radiotherapy improves oncologic outcomes in prostate cancer patients who develop biochemical recurrence after radical prostatectomy.

4. nature.com nature.com/articles/s41391-024-00883-3

Local salvage therapies in patients with radio-recurrent ... Overall, pooled 2-year and 5-year RFS were higher after re-irradiation salvage procedures. Indeed, 2-year RFS were 84% and 69% following salvage ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.01391

Salvage Reirradiation for Locally Recurrent Prostate Cancer The actuarial 5-year local recurrence-free survival was 93% (95% CI, 82 to 100), metastasis-free survival was 82% (95% CI, 69 to 95), and ...

6. clinicaltrial.be clinicaltrial.be/en/details/75586?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

MRI-Mapped Dose-Escalated Salvage Radiotherapy Post ... The mapped tumor (MT) boost region will receive an absolute dose of 76.5 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 80 Gy in ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405630825001296

Salvage stereotactic MR-Guided adaptive radiotherapy ... Salvage SABR is an effective and safe option for LRPC, but challenges remain. •. Daily adaptation SMART enables high target coverage while sparing OAR.

8. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2839396

Prostate-Specific Membrane Antigen PET-Guided ... Third, it is known that most patients develop considerable clinical adverse effects after completing RT but tend to recuperate after 12 months ...