NCT03533946: ROAR

Rucaparib in Nonmetastatic prOstAte With BRCAness

Terminated Phase 2 Results posted Last updated 13 March 2024

What this trial tests

Phase 2 trial testing Rucaparib in Prostate Cancer in 7 participants. Terminated before completion.

Timeline

20 May 2019

Primary endpoint
12 January 2023

12 January 2023

Quick facts

Lead sponsor	University of Utah
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	20 May 2019
Primary completion	12 January 2023
Estimated completion	12 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Rucaparib (RUCAPARIB) — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

University of Utah

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Prostate Specific Antigen Progression Free Survival Primary · From baseline to up to 2 years after study treatment discontinuation; actual max approximately 42 months

The levels of PSA were monitored monthly for comparison to baseline levels until the time of PSA progression, or 2 years after study treatment discontinuation, or study termination, as defined by Prostate Cancer Working Group 3 (PCWG3) criteria. PCWG3 criteria for PSA progression is a rise over baseline of \>= 25% and an absolute rise of \>= 2 ng/mL. Reported as median number of months from baseline to PSA progression.

Group	Value	95% CI
Rucaparib, All Participants	35.37	0 – 85.11

Number of Participants With Adverse Events (AEs) Related to Rucaparib Secondary · From first dose of study treatment until 30 days after last dose of study treatment; max 42 months

To assess the safety of rucaparib in participants with biochemically recurrent hormone-sensitive prostate cancer. Severity of adverse events was assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity, where Grade 1 indicates "mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated" and Grade 5 indicates "death related to AE." Each adverse event was also evaluated by the treating investigator to assess its attribution to rucaparib, with options being unrelated, unlikely related, possibly related, probabl

Grade 1

Group	Value	95% CI
Rucaparib, All Participants	7

Grade 2

Group	Value	95% CI
Rucaparib, All Participants	4

Grade 3

Group	Value	95% CI
Rucaparib, All Participants	2

Count of Participants With an Undetectable PSA at 6 and 12 Months Secondary · At 6 and 12 months after initiation of study therapy

To assess the percentage of participants with an undetectable PSA after initiation of study therapy at 6 and 12 months. Endpoint: the levels of PSA will be monitored monthly for comparison to baseline levels to determine when PSA becomes undetectable. Participants who were not followed for at least 6 months after initiation of study therapy were not able to be evaluated for this time point.

At 6 months

Group	Value	95% CI
Rucaparib, All Participants	1

At 12 months

Group	Value	95% CI
Rucaparib, All Participants	1

Overall Survival (OS) at 2 Years Secondary · From start of study treatment until up to 2 years after study treatment discontinuation; actual max approximately 42 months

To evaluate OS in nonmetastatic hormone-sensitive prostrate cancer participants treated with rucaparib. Calculated as the number of participants alive 2 years after study treatment discontinuation or study termination.

Group	Value	95% CI
Rucaparib, All Participants	7

Count of Participants With 50% or Greater Reduction in PSA Levels Secondary · From baseline until up to 2 years after study treatment discontinuation; actual max approximately 42 months

To assess the number of participants with a 50% reduction in PSA levels (PSA50) compared to the baseline value at the time of study enrollment. The levels of PSA will be monitored monthly for comparison to baseline levels.

Group	Value	95% CI
Rucaparib, All Participants	2

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rucaparib, All Participants

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (57 terms — click to expand)

Reaction	System	Rucaparib, All Participants
Fatigue	General disorders	—
Alanine aminotransferase increased	Investigations	—
Dysgeusia	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Surgical and medical procedures - Other, specify	Surgical and medical procedures	—
Anemia	Blood and lymphatic system disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Anorexia	Metabolism and nutrition disorders	—
Aspartate aminotransferase increased	Investigations	—
Flatulence	Gastrointestinal disorders	—
Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	—
Headache	Nervous system disorders	—
Hot flashes	Vascular disorders	—
White blood cell decreased	Investigations	—
Alkaline phosphatase increased	Investigations	—
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Bloating	Gastrointestinal disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Creatinine increased	Investigations	—
Dry mouth	Gastrointestinal disorders	—
Fall	Injury, poisoning and procedural complications	—
Flank pain	Musculoskeletal and connective tissue disorders	—
Gastric ulcer	Gastrointestinal disorders	—
Hematoma	Vascular disorders	—
Hematuria	Renal and urinary disorders	—
Hypertension	Vascular disorders	—
Hypoglycemia	Metabolism and nutrition disorders	—
Infections and infestations - Other, specify	Infections and infestations	—
Insomnia	Psychiatric disorders	—
Irritability	Psychiatric disorders	—
Localized edema	General disorders	—
Memory impairment	Nervous system disorders	—
Mucositis oral	Gastrointestinal disorders	—
Muscle cramp	Musculoskeletal and connective tissue disorders	—
Musculoskeletal and connective tissue disorder - Other, specify	Musculoskeletal and connective tissue disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Nail ridging	Skin and subcutaneous tissue disorders	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—
Neck pain	Musculoskeletal and connective tissue disorders	—

Data from ClinicalTrials.gov NCT03533946 adverse events section.

Sponsor's own description

This is a single arm, open label, phase II trial to assess efficacy of rucaparib.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. DNA Repair Pathways in Cancer Therapy and Resistance.
   Li LY, Guan YD, Chen XS, Yang JM, et al · · 2020 · cited 254× · PMID 33628188 · DOI 10.3389/fphar.2020.629266
2. Prostate cancer and PARP inhibitors: progress and challenges.
   Teyssonneau D, Margot H, Cabart M, Anonnay M, et al · · 2021 · cited 103× · PMID 33781305 · DOI 10.1186/s13045-021-01061-x
3. Genetic aberrations in DNA repair pathways: a cornerstone of precision oncology in prostate cancer.
   Lozano R, Castro E, Aragón IM, Cendón Y, et al · · 2021 · cited 81× · PMID 33106584 · DOI 10.1038/s41416-020-01114-x
4. PARP Inhibitors and Prostate Cancer: To Infinity and Beyond BRCA.
   Risdon EN, Chau CH, Price DK, Sartor O, et al · · 2021 · cited 77× · PMID 32790034 · DOI 10.1634/theoncologist.2020-0697
5. BRCA2 and Other DDR Genes in Prostate Cancer.
   Nombela P, Lozano R, Aytes A, Mateo J, et al · · 2019 · cited 68× · PMID 30871108 · DOI 10.3390/cancers11030352
6. Targeting DNA Damage Response in Prostate and Breast Cancer.
   Wengner AM, Scholz A, Haendler B. · · 2020 · cited 60× · PMID 33158305 · DOI 10.3390/ijms21218273
7. PARP Inhibitors in Prostate Cancer—The Preclinical Rationale and Current Clinical Development.
   Virtanen V, Paunu K, Ahlskog JK, Varnai R, et al · · 2019 · cited 43× · PMID 31357527 · DOI 10.3390/genes10080565
8. Exploring anti-androgen therapies in hormone dependent prostate cancer and new therapeutic routes for castration resistant prostate cancer.
   Harris AE, Metzler VM, Lothion-Roy J, Varun D, et al · · 2022 · cited 30× · PMID 36263323 · DOI 10.3389/fendo.2022.1006101